 |
Chronological List of Petitions
and Advisory Opinions
From January 1, 2003 through December 30, 2003
To view actual
documents, make a note of the docket number. Click on http://www.fda.gov/search.html, enter the docket number. You will
then get everything associated with that docket number.
"65FR78494"
indicates a notice of some type was published in the Federal Register
(FR) for a particular date. The FR can be found at http://www.fda.gov/ohrms/dockets/ and then go to the Federal Register
section.
You can search
this list by using the "edit" pull down menu and then
the "find" command from the above toolbar. Unfortunately,
to make the font (type) any larger will cause the text to wrap into
the next line and increase the length of the document.
Int. or Interim
is an interim response, does not necessarily indicate any type of decision. It
may state only that the agency has not yet reviewed their petition.
Approved or
denied depends on what the petitioner requested. It is important
to read the response letter and petition to get the correct decision.
We are unable
to post/link all documents at this time but are working towards
that goal.
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| CHRONOLOGICAL
LIST OF PETITIONS AND ADVISORY OPINIONS
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| Date
Filed
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| Docket
#
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| Name
of Petitioner/Subject Matter
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| Disposition
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| 01/02/2003
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| 2003V-0003
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| R. J. Enterprises/Laser
light show
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| 01/03/2003
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| 2003V-0004
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| John Weber/Laser
Light show
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| 01/06/2003
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| 2003P-0006
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| Lachman
Consultant Services, Inc./Determine if Levorphanol Tartrate
withdrawn for safety reaso
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| Withdrawn 4/20/06
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| 01/06/2003
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| 2003V-0005
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| Baton Rouge
Communications/Laser Light Show
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| 01/10/2003
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| 2003V-0012
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| Revision
Entertainment/Laser Light Show
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| 01/16/2003
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| 2003P-0013
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| First Priority,
Inc./ANADA Privermectin Equine Oral Liquid for Horses
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| 01/22/2003
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| 1975N-0183H
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| CTFA and
Soap and Detergent Association/Health-Care Antiseptic Drug Products
for OTC Human Use
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| INTERIM
RESPONSE 05/15/2003 Int: 5/15/03
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| 01/23/2003
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| 2003P-0021
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| Amphastar
Pharmaceuticals, Inc./Withdrawal of Wydase, Hyaluronidase Injection
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| INTERIM
RESPONSE 07/14/2003 , Answered 11/06/2003
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| 01/23/2003
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| 2003V-0019
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| Stefano
Moris/Laser Light Projector
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| 01/23/2003
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| 2003V-0020
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| Friction
Events/Laser Light Show
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| 01/23/2003
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| 1978N-0227
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| Ethex Corporation/Trimethobenzamide
Hydrochloride Injection & Capsules
| DENIED 12/29/2003
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| 01/23/2003
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| 1988V-0165
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| Laser Image
Productions, Inc./Variance re Laser light show projector (LIP-88-1)
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| 01/28/2003
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| 2001P-0290
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| Hodgson
Mill/Definition for the term "stone ground" for wheat
flour
| DENIED 12/24/2003
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| 01/28/2003
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| 2001P-0290
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| Hodgson
Mill/Definition for the term "stone ground" for wheat
flour
| DENIED 12/24/2003
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| 01/28/2003
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| 2003P-0027
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| Eoc Labs,
Inc./Amend labeling for skelaxin (metaxalone) tablets to restore
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| INTERIM RESPONSE
07/20/2003
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| 01/28/2003
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| 2003V-0026
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| Long Beach
Transit/Laser Light Show
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| 01/29/2003
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| 2003V-0028
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| Queen Street
Inc. DBA "Wibs"/Laser Light Show
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| 01/29/2003
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| 2003P-0029
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| American
Lung Association/Remove metered-dose inhalers (MDI) containing
moiety albuter
| Approved 07/15/2004 |
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| 01/30/2003
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| 2003P-0039
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| Orphan Medical/Policy
regarding users fee and Orphan Drug
| Withdrawn 08/11/2006 |
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| 01/31/2003
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| 2003P-0041
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| Bunker Hill
Cheese Co., Inc./Exemption of Section 403 for application of
Name Yogurt Chee
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| 01/31/2003
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| 2003V-0042
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| Laserwurx,
LLC/Laser Light Show Projector
| Approved 06/08/2005; Termination date 03/07/2008
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| 02/04/2003
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| 2003V-0047
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| Lightwave
Lasers/Projector Model Number 3130 for Laser Light Show
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| 02/07/2003
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| 2003V-0052
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| Lance Pilon/Laser
Light Show
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| APPROVED
09/29/2003 Approved 09/29/2003;Expires 09/29/2005
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| 02/11/2003
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| 2003V-0054
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| Louis J.
Roussel, Jr. Planetarium/Laser Light Show
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| 02/11/2003
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| 2003V-0055
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| Steve Carlson/Laser
Light Skhow
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| 02/11/2003
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| 2003V-0073
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| Mr. Alex
Tseng/A laser display device
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| 02/13/2003
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| 2002P-0462
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| Carbolite
Foods, Inc./Use of Implied Nutrient Content Claim - "Carbolite"
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| 02/13/2003
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| 2003P-0067
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| Rapid Precision
Testing Labs./Amend CFR to include provision to establish prescription
sun
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| Denied 6/16/2003;PDN1
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| 02/13/2003
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| 2003V-0058
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| SHOWLASERS
INC/Laser Light Show
| Closed 03/03/2003 Moved to 1980P-0495
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| 02/13/2003
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| 1977N-0094
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| Bayer Healthcare,
LLC/OTC Internal Analgesic, Antipyretic & Antirheumatic
Products
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| INTERIM
RESPONSE 08/08/2003
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| 02/19/2003
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| 2003P-0064
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| Aventis
Pharmaceuticals Inc./Withhold Approval of Generic Lovenox (enoxaparin
sodium inje
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| 02/25/2003
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| 2003V-0071
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| Rhythm of
the Road/Laser Light Show
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| 02/26/2003
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| 2003V-0072
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| ADJ Connection/Laser
Light Show
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| 02/26/2003
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| 2003V-0074
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| Synergy
Laser & Image/Laser Light Show
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| 02/27/2003
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| 2003P-0078
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| American
Spice Trade Assn, Assn. of Food/Public Health Security &
Bioterrorism Preparedness & Response
| Interim
Response 11/04/03 |
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| 02/28/2003
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| 2003V-0080
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| Sierra Flo
Co., LLC/Laser Light Show
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| APPROVED
06/23/2003 ;Terminates 6/23/2005
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| 03/04/2003
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| 2003P-0082
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| Lachman
Consultant Services, Inc./Abbreviated New Drug Application (ANDA)
for Ursodiol Oral
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| APPROVED
08/13/2003
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| 03/04/2003
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| 2003P-0083
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| Taro Pharmaceuticals,
U.S.A., Inc./ANDA suitability for carbamazepine tablets, 100mg,
300mg,400
| APPROVED 12/17/2003
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| 03/06/2003
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| 2003P-0089
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| Andrx Pharmaceutical,
Inc./Loratadine in 10 Milligrams Orally Disintegrating Tablets
| Denied 10/9/03 |
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| 03/07/2003
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| 2002P-0321
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| John Keeler
& Co./Grant relief unwarranted testing for chloramphenicol
crabmea
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| DENIED 07/29/2003
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| 03/07/2003
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| 2003P-0090
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| Public Citizen/Removing
Serzone (nefazodone) from the market Bristol-Myers
| Denied 06/14/2004 |
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| 03/07/2003
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| 2003P-0091
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| Lachman
Consultant Services, Inc./ANDA to declare that drug prod Hydrocodone
Polistirex & Chlo
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| 03/12/2003
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| 2002P-0285
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| King &
Spalding LLP/Combination oxycodone hydrochloride/acetaminophen
tablet
| Denied 07/30/2004 |
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| 03/12/2003
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| 2003V-0095
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| FX Unlimited/Laser
Light Show
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| CHRONOLOGICAL
LIST OF PETITIONS AND ADVISORY OPINIONS
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| Date
Filed
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| Docket
#
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| Name
of Petitioner/Subject Matter
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| Disposition
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| 03/12/2003
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| 2003V-0096
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| P A Systems & Lighting/Laser
Light Show
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| 03/13/2003
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| 2003P-0097
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| Jones Pharma/Unithroid
as reference listed drug for levothyroxine sodium
| ANSWER 10/01/2003 Petition
is moot in part and denied in part 10/1/2003
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| 03/13/2003
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| 2003V-0098
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| Digital Smoke and Mirrors/Laser
Light Show
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| APPROVED 05/15/2003
Approved 5/15/03
Terminated
5/15/05
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| 03/13/2003
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| 2003V-0099
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| Siemens Medical Solutions
USA, Inc./Aluminum Equivalent Cantilevered Tabletop Angiography
System
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| 03/13/2003
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| 2003V-0100
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| Beam Bouncers Inc./Laser
Light Show
| Approved 05/15/2006
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| 03/13/2003
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| 2003V-0101
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| Bedroxx/Laser Light Show
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| 03/14/2003
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| 2003P-0105
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| Mettler Electronics Corp./Revoke
Medical Device Tracking Order
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| ANSWER 05/28/2003 Withdrawn
05/28/2003
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| 03/17/2003
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| 2003V-0103
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| The Quest/Laser Light
Show Red-Lin #XYP-1000/2 Controller,XYP-1000Head
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| 03/20/2003
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| 2003P-0107
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| Mylan Pharmaceuticals
Inc./Synthroid (levothyroxine sodium) Tablets (NDA 21-402)
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| 03/20/2003
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| 2003P-0108
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| Cross Vetpharm Group,
Ltd./Permit ANADA for Apramycin Sulfate Soluble Powder
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| Approved 6/4/2003
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| 03/20/2003
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| 2003P-0109
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| American Herbal Products
Assn./Promulgate regulation mandating adverse reporting for dietar
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| 03/20/2003
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| 2003P-0110
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| Faulding Pharmaceutical
Company/ANDA Suitability for Epirubicin Hydrochloride Injection
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| APPROVED 08/13/2003 Approved
August 13, 2003
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| 03/21/2003
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| 2003P-0113
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| Mylan Pharmaceuticals,
Inc./Levoxyl (levothyroxine sodium) tablets (NDA #21-301)
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| 03/25/2003
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| 2001P-0573
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| National Center for Tobacco-Free
Kids/Petition for Regulation of S & F Nicotine Water
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| 03/25/2003
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| 2003P-0119
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| Lachman Consultants
Services, Inc./ANDA for Methadone Hydrochloride Tablets USP,15mg,20mg,30mg
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| 03/25/2003
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| 1981N-0033A
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| Sinofresh Research Labs,
LLC/Oral Health Care Drug Product; Oral Antiseptic Drug Products
| Denied 04/21/2005
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| 03/26/2003
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| 2003P-0121
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| Biovail Corporation/Enforcing
the patent certification requirements in FD&C Act
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| INTERIM RESPONSE 09/23/2003
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| 03/27/2003
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| 2003P-0123
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| Orthopedic Surgical Mfrs
Assn (OSMA)/Reclassification for Polymethylmethacrylate Bone Cement
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| 03/27/2003
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| 2003V-0124
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| Universal Studios Florida/Laser
Light Show
| Approved 06/16/2005; Termination
date 04/14/2008
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| 03/28/2003
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| 2003P-0126
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| Jones Pharma
Inc.(Jones) King Pharma./Refrain from approving (ANDA)for Levothyroxine
Sodium Tablet
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| INTERIM RESPONSE
09/16/2003
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| 03/28/2003
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| 2003V-0125
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| Insight Technology Incorporated/Infrared
Laser Aiming Device
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| Approved 05/09/2003; Approved
12/26/2006
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| 04/01/2003
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| 2003V-0127
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| Entertainment Service/Laser
Light Show
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| 04/01/2003
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| 2003V-0129
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| Plur Entertainment LLC.d.b.a
Club Fusion/Laser Light Show
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| 04/01/2003
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| 2003V-0130
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| Introspective Laser Lighting
ECT., LTD/Laser Light Show
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| Approved 06/06/2003
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| 04/01/2003
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| 2003V-0131
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| Laser Design Productions/Laser
Light Show
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| APPROVED 11/03/2003;
Approved 05/19/2005; Termination date: 05/20/2005
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| 04/02/2003
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| 2003P-0132
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| International Dairy Foods
Association/Part 135 FDA regulations standard of identity frozen
dessert
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| INTERIM RESPONSE 09/26/2003
Int: 09/26/2003
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| 04/02/2003
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| 2003P-0162
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| J.M. Investments, Inc.
D.B.A. Lucky/Import Canadian food products that do not meet labeling
regs
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| WITHDRAWN 08/22/2003 Withdrawn
8/22/2003
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| 04/03/2003
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| 2003V-0133
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| Restaurant Tatiana/Laser
Light Show
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| Approved 05/07/2003 Approved
06/01/2006
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| 04/07/2003
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| 2003V-0138
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| KDPS/Laser Light Show
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| APPROVED 06/26/2003 Approved
June 26, 2003
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| 04/07/2003
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| 2003V-0155
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| Mojo-Laser/Laser light
show
|
| APPROVED 05/12/2003 Approved
5/12/03
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| 04/08/2003
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| 2003P-0140
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| GlaxoSmithKline/Refrain
from Approving ANDAs for Topical Mupirocin Ointment
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| INTERIM RESPONSE 09/25/2003
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| 04/14/2003
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| 2003V-0156
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| Epic Beat Productions/Laser
Light Show Projector
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| 04/14/2003
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| 2003P-0340
|
| Spectral Diagnostics,
Inc./Request for Evaluation of Automatic Class III Designation (De
Novo) for Endotoxin Activity Assay (EAA) (K021885)
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| APPROVED 10/31/2003
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| 04/16/2003
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| 2003P-0159
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| Lachman Consultant Services,
Inc./Venlafaxine Hydrochloride Extended-Release Tablets
| APPROVED 03/30/2005
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| 04/16/2003
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| 2003P-0160
|
| Genpharm, Inc. of Etobicoke
(Canada)/FDA to send letter ruling refusing to approve loratadine
tab
| INTERIM RESPONSE 10/23/2003
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| 04/18/2003
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| 2003P-0166
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| Associated Pharmacologists
& Toxicologis/Revoke Approval for Marketing of Menstrual Cups
| Answer 11/18/2003
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| 04/23/2003
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| 2003P-0171
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| Del Monte Corp./Amend
the standard of identity for canned tomatoes.
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| INTERIM RESPONSE 09/26/2003
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| 04/24/2003
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| 2003P-0176
|
| Biotechnology Industry
Organization/Follow-Up Approval of Therapeutic Protein Products
| Answer 05/30/2006 |
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| 04/25/2003
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| 2003P-0178
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| Lachman Consultant Services,
Inc./ANDA Suitability for Divalproex Sodium Extended-Release Tabs
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| 04/25/2003
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| 2003V-0177
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| Lighting & Sound Consultants/Laser
Light Show
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| 04/28/2003
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| 2003V-0179
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| Musititlan Entertainment/Laser
Light Show
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| APPROVED 08/19/2003 Approved
August 19, 2003
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| 05/01/2003
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| 2003P-0183
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| Hawaii Pride, LLC/180
Day Tentative responses under 21CFR5.10/21CFR 10.30
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| 05/01/2003
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| 2003P-0184
|
| Samson Medical Technologies,
L.L.C./Permit filing of ANDA for nafcillin for injection, USP, phar
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| CHRONOLOGICAL
LIST OF PETITIONS AND ADVISORY OPINIONS
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| Date
Filed
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| Docket
#
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| Name
of Petitioner/Subject Matter
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| Disposition
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| 05/01/2003
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| 2003V-0185
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| Creative Consultants,
LLC/Laser Light Show
|
| Approved 05/27/2003, Approved 03/31/2005
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| 05/05/2003
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| 2003P-0188
|
| The Weinberg Group Inc./ANDA
Suitability for Glyburide & Metformin HCl Tablets
| Approved 07/30/2004 |
|
| 05/07/2003
|
| 2003V-0192
|
| Fun Factory Mobile DJs/Laser
Light Show
|
| APPROVED 05/29/2003
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| 05/08/2003
|
| 2003P-0196
|
| Pharmacists
Planning Services, inc./Switch Nicotrol Inhaler (nicotine Inhalation
System) From Prescription to Over the Counter Status
| Denied 04/02/2004
|
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|
| 05/13/2003
|
| 2003P-0107
|
| Abbott Laboratories/Synthroid
(levothyroxine sodium) Tablets (NDA 21-402)
| DENIED 11/07/2003
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|
| 05/13/2003
|
| 2003P-0113
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| Abbott Laboratories/Levoxyl
(levothyroxine sodium) tablets (NDA #21-301)
| DENIED 11/07/2003
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|
| 05/14/2003
|
| 2003P-0218
|
| The Weinberg Group Inc./ANDA
for Glipizide and Metformin HCI Tablets for Oral Solution
| Approved 07/30/2004 |
|
| 05/15/2003
|
| 2003P-0220
|
| Faulding Pharmaceutical
Company/ANDA for Carboplatin, 10mg/mL, in strength of 600 mg/60
mL
| APPROVED 10/01/2003
|
|
| 05/19/2003
|
| 2003P-0214
|
| Mutual Pharmaceutical
Company/Correct the listing of Quinidine extended-release tablets
in Orange Book
|
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|
| 05/19/2003
|
| 2003P-0219
|
| Vetoquinol N.-A. Inc./ANADA
Suitability for Amoxicillin Oral Paste
|
| APPROVED 07/31/2003
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|
| 05/21/2003
|
| 2003V-0208
|
| Laser Entertainment SRL/Laser
Light Show
|
|
|
| 05/21/2003
|
| 2003P-0210
|
| Abbott Laboratories/Withdraw
decision granting petitions 03P-0107 and 03P-0113
| DENIED 11/07/2003
|
|
| 05/23/2003
|
| 2003V-0215
|
| US Air Force Research
Laboratory/Laser Light Show
|
|
|
| 05/23/2003
|
| 2003P-0216
|
| HRA Pharma/ANDA
for a drug product(1.5 mg levonorgestrel tablet) in strength(Plan
B 0.75 mg Levonorgestrel tablet) in strength
| DENIED 12/17/2003
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|
| 05/23/2003
|
| 2003P-0217
|
| Ranbaxy Laboratories
Limited/Concept of shared exclusivity for multiple ANDA submitted
on the same day
| CLOSED 07/31/2003 |
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|
| 05/23/2003
|
| 1975N-0183H
|
| CTFA and SDA/Health-Care
Antiseptic Drug Products for OTC Human Use
|
| APPROVED 07/07/2003
|
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|
| 05/23/2003
|
| 2003P-0223
|
| Richdel, Inc./ANADA Suitability
for Ivermectin
|
| APPROVED 07/31/2003
|
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|
| 05/23/2003
|
| 1994P-0036
|
| Bantransfats.com/Req labeling
of trans fatty acid & prohibit deceptive claims
|
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|
| 05/27/2003
|
| 2003P-0227
|
| Samson Medical Technologies,
LLC/ANDA Suitability Petition for Cefoxitin
| APPROVED 10/01/2003
|
|
| 05/27/2003
|
| 2003V-0230
|
| River Palms Resort Casino/Laser
Light Show
|
| APPROVED 06/23/2003;
Terminates 6/23/2005
|
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| 05/28/2003
|
| 2003P-0301
|
| Assurance Medical, Inc./Classification
of the Breast Lesion Documentation System
|
| APPROVED 07/28/2003
|
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|
| 06/02/2003
|
| 2003P-0258
|
| Erick Swanson/Carotenoid
astaxanthin to have the label " color added" or artificial
color
|
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|
| 06/03/2003
|
| 2003P-0237
|
| United Research
Laboratories, Inc./ANDA Suitability Petition for Propranolol HCI
Extended-Release Tablets, 60 mg, 80 mg, 120 mg and 160 mg
| APPROVED 10/01/2003
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| 06/03/2003
|
| 2003P-0238
|
| The Weinberg Group Inc/ANDA
Suitability Petition for Clarithromycin Extended-Release Tablets
| APPROVED 12/18/2003
|
|
| 06/05/2003
|
| 2003V-0239
|
| GEKD, Inc./Laser Light
Show
|
| APPROVED 07/30/2003
;Terminated 07/30/2005
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|
|
|
|
| 06/10/2003
|
| 2003V-0265
|
| Nier of Texas,
Inc. DBA South Beach/South Beach Laser Light Show and Projector
Laser Spectacles Luxme 3003
|
| APPROVED 07/10/2003
|
|
|
|
|
|
|
|
|
| 06/11/2003
|
| 2003P-0266
|
| Olsson,Frank
and Weeda,P.C./Lovenos(enoxaparin sodlium),NDA 20-164(90mg/0.6ml(product
number 006),was not withdrawn from sale for reasons of safety or
effectiveness sponsored by Aventis Pharmaceuticalls inc.
| Answer 03/08/2004
|
|
|
|
|
| 06/11/2003
|
| 2003P-0270
|
| Compassion Over Killing,
Inc/Prohibit False and Misleading Labeling
| INTERIM RESPONSE 12/05/2003
|
|
| 06/13/2003
|
| 2003P-0274
|
| Abigail Alliance and the
Washington Legal Foundation/In re Tier 1 initial Approval Program
| INTERIM RESPONSE 12/16/2003
|
|
| 06/16/2003
|
| 2003P-0275
|
| Allergan Inc./Reclassify
Cyclosporine (CSA) as Non-antibiotic Drug
| DENIED 12/18/2003
|
|
| 06/17/2003
|
| 2003P-0276
|
| CSPI/Establish Interim
Acceptable Levels for Acrylamide In Major Food Sources
| Interim Response 11/21/2003
|
|
| 06/17/2003
|
| 2003P-0277
|
| Arthur Young/Indicate
to Potential Users of a Drug by Means of Labeling Whether Any Product
Had Used Human Embryo or Material Derived From Human Embryos in
Its Development, Production or Testing
|
|
|
|
|
|
|
|
|
|
|
|
| 06/18/2003
|
| 2003P-0278
|
| Cape Cod, Inc./Regulate
recombinant and any other previously unlicensed endotoxin detection
tests for validation, in-process and finished product endotoxin
testing od drugs
| INTERIM RESPONSE 12/08/2003
|
|
|
|
|
|
|
|
| 06/18/2003
|
| 2003P-0279
|
| Jerussi Consulting,
Inc./Abbreviated New Drug Application for a Topical solution of
the three actives fluocinolone acetonide, hydroquinone, and tretinoin
| Denied 04/01/2005
|
|
|
|
|
| 06/18/2003
|
| 2003P-0280
|
| Cape Cod, Inc./Determine
that a recombinanat endotoxin tests intended for endotoxin testing
of
| INTERIM RESPONSE 12/08/2003
|
Top
|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
|
|
|
|
| CHRONOLOGICAL
LIST OF PETITIONS AND ADVISORY OPINIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
| Date
Filed
|
| Docket
#
|
| Name
of Petitioner/Subject Matter
|
| Disposition
|
|
|
|
|
| 06/19/2003
|
| 2003P-0283
|
| Lachman Consultant
Services, Inc./ANDA Suitable for Glimepiride Tablets, 8 mg
| APPROVED 10/06/2003
|
|
| 06/19/2003
|
| 2003P-0284
|
| Lachman
Consultant Services, Inc./Lexapro (escitalopram oxalate) tablets
5mg (NDA 21-323, Product 001),mfged by Forest Laboratories have
been voluntarily withdrawn or withheld from sale for safety or efficacy
reasons
| Withdrawn 01/26/2004
|
|
|
|
|
|
|
|
|
|
|
| 06/19/2003
|
| 2003P-0291
|
| Tim Milburn
O.D./Enforce the law and prevent unlaw sale of contact lens
| Denied 06/28/2004 |
|
| 06/20/2003
|
| 2003P-0288
|
| Family Care
Health Centers/Health Center, be deemed a " pharmacy of an
other health care entity"
| APPROVED 12/10/2003
|
|
| 06/23/2003
|
| 2003P-0289
|
| Diana E. Kelly/outlaw
and prohibit the use of hydrogenated and partially hydrogenated
fats in all prepared,manufactured and processed food products intended
for human consumption
| DENIED 12/19/2003
|
|
| 06/23/2003
|
| 2003V-0293
|
| Lumalaser/Laser
Light Show
|
| APPROVED 07/01/2003; Approved
08/25/2006
|
|
|
| 06/23/2003
|
| 2003N-0234
|
| Crown
Cork & Seal Company/Canned Asparagus Deviating From Identity
Standard; Temporary Permit for Market Testing
|
| APPROVED
06/18/2003 Notice of Temproary Marketing Permit June 18, 2003 68FR36567
|
|
|
|
|
|
|
|
|
|
|
| 06/24/2003
|
| 2003P-0292
|
| Samson
Medical Technologies, L.L.C./to permit the filing of an ANDA for
a Ceftazidime for Injection,UPS,phamacy bulk package in a 100 gram
dosage strength packaged in plastic bags that are contained within
foil outer wraps
| APPROVED 12/23/2003
|
|
|
|
|
|
|
|
|
|
|
| 06/26/2003
|
| 1978N-0036L
|
| C.B. Fleet Company/OTC
Laxative
| INTERIM RESPONSE 01/05/2004
|
|
| 06/27/2003
|
| 2003P-0297
|
| Peter M. Rothenberg,
M.D., MA./Exemption from 510(k) process for an Accessory to Electrode
Cable
|
| CLOSED 08/12/2003
Withdrawn August 12, 2003
|
|
|
| 06/30/2003
|
| 2003P-0298
|
| The Weinberg
Group, Inc./Diclofenac Potassium Capusles 25 mg suitable for submission
as ANDA
| Interim Response 02./03/2004 |
|
| 06/30/2003
|
| 2003P-0300
|
| The
Weinberg Group Inc./Cataflam (diclofenac potassium) Tablets 25 mg
(NDA 20-142 voluntarily withdrawn or wtihheld from sale for safety
or effectiveness reasons
| Answer 11/18/2003
|
|
|
|
|
| 07/03/2003
|
| 2003P-0450
|
| PANBIO Limited/De
Novo Petition for West Nile Virus IgM Capture ELISA
|
|
|
| 07/07/2003
|
| 2003V-0306
|
| Visiotopic System
LLC/Laser Light Show
| Approved 12/04/2006 Terminates after
12/08/2008 |
|
| 07/07/2003
|
| 2003P-0307
|
| Taro Pharmaceuticals
/ANDA suitability for a new strength of Warfarin Sodium Tablets,
USP 1.5mg
| APPROVED 10/06/2003
|
|
| 07/07/2003
|
| 1978N-0021
|
| CTFA/Skin Protectant
Drugs for OTC Human Use
| Approved in part and denied in part 02/24/2004
|
|
| 07/07/2003
|
| 1978N-0021P
|
| CTFA/Skin Protectant
Drug Products for OTC Human Use
| Approved in part and denied in part 02/24/2004
|
|
| 07/07/2003
|
| 1978N-0064
|
| Revlon, Inc./OTC
Antiperspirant
|
|
|
| 07/07/2003
|
| 2003P-0310
|
| Baldwin Richardson
Foods, Co./Nance Pretzel Dip
|
| WITHDRAWN 08/27/2003
|
|
|
| 07/08/2003
|
| 2003P-0304
|
| Taro
Pharmaceuitcals USA, Inc./ANDA suitability for Carbamazepine Oral
Suspension USP,200 mg/mL based on the reference-listed drug
|
|
|
|
|
|
| 07/09/2003
|
| 1978N-0064
|
| CTFA/OTC Antiperspirant
| Approved in part and Denied in part 02/17/2005
|
|
| 07/15/2003
|
| 2003P-0315
|
| CollaGenex
Pharmaceuticals/Doxycycline hyclate tablets 20 mg in which bioequivalence
of the Mutual product to CollaGened Periostat , the reference listed
drug
| Denied 05/13/2005
|
|
|
|
|
|
|
|
| 07/15/2003
|
| 2003V-0316
|
| Imagery Laser/Laser
Light Show
| APPROVED 11/10/2003; Terminated
11/10/2005
|
|
| 07/17/2003
|
| 2003P-0321
|
| ICN
Pharmacuticals, Inc. and Ribapharm /Refrain from approving an Abbreviated
New Drug Application (ANDA's) for Riavirin
| Interim Response 01/30/2004,
Denied 04/06/2004 |
|
|
|
|
|
|
|
| 07/21/2003
|
| 2003P-0322
|
| number not used/number
not used
|
|
|
| 07/22/2003
|
| 2003P-0315
|
| CollaGenex
Pharmaceuticals/Doxycycline hyclate tablets 20 mg in which bioequivalence
of the Mutual product to CollaGened Periostat , the reference listed
drug
| Denied 05/13/2005
|
|
|
|
|
|
|
|
| 07/23/2003
|
| 2003P-0331
|
| Lachman
Consultant Services, Inc./ANDA Suitability for Hydrocodone Bitartrate
and Ibuprofen Tablets (5 mg/400mg; 7.5 mg/400 mg and 10 mg/400 mg)
| Denied 04/01/2005
|
|
|
|
|
| 07/31/2003
|
| 2003V-0100
|
| Beam Bouncers
Inc./Laser Light Show
|
| APPROVED 08/29/2003
|
|
|
| 08/06/2003
|
| 2003P-0275
|
| Allergan, Inc./Reclassify
Cyclosporine (CSA) as Non-antibiotic Drug
| DENIED 12/18/2003
|
|
| 08/06/2003
|
| 2003V-0354
|
| Cashier Astroonomical
Observers, Inc./Laser light Show
|
| APPROVED 08/27/2003
|
|
|
| 08/07/2003
|
| 2003P-0357
|
| Beth
Rosenshein/Update the Drug/Laboratory Test Interactions section
of the prescribing information of all strenghts of Premarin tablets
(.3mg, .45mg, .625mg, 1.25mg, 2.5mg) to recognize the decfeased
levels of testo
| Approved and denied in part 09/21/2004 |
|
|
|
|
|
|
|
|
|
|
| 08/11/2003
|
| 2003P-0358
|
| Caruso
Pharmaceutical Consultation Services/Methenex (Methadone Hydrochloride
40 mg,Naloxone Hydrochloride 2 mg) tablets (effervescent) NDA 17-491/NDA
17-490 withdrawn,discontinued from marketing or withhjeld from sale
for safety or efficacy
|
|
|
|
|
|
|
|
|
|
|
|
| 08/11/2003
|
| 2003V-0359
|
| OUO Entertainment
Corporation/Laser Light Show
|
| APPROVED 08/27/2003
|
|
Top
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| CHRONOLOGICAL
LIST OF PETITIONS AND ADVISORY OPINIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
| Date
Filed
|
| Docket
#
|
| Name
of Petitioner/Subject Matter
|
| Disposition
|
|
|
|
|
| 08/11/2003
|
| 2003P-0362
|
| Etymotic
Research, Inc./Over-the-counter Hearing Aids
| Denied 02/13/2004 |
|
| 08/11/2003
|
| 2003P-0363
|
| GudHear,
Inc./Professional and Patient Labeling for Hearing Aid Devices
| Denied 02/13/2004 |
|
| 08/12/2003
|
| 2003V-0368
|
| Laser Vision
Club Statlk/Laser Artistry Projector
|
|
|
| 08/13/2003
|
| 2003P-0365
|
| Jerussi
Consulting, Inc./Galderma product, solage containing 2% Mequinol,
and 0.01% tretinoin, NDA 20-922 can be formulated as a topical
solution with the substitution of Hydroquinone at 4% for the
2% mequinol as an ANDA
| Denied 12/02/2004
|
|
|
|
|
|
|
|
|
|
|
| 08/13/2003
|
| 2003P-0366
|
| Mattingly,
Stanger & Malur, P.C./Amend approval for a nonprescription
form of Prilosec (omeprazole magnesium)
| Denied 01/21/2005
|
|
|
|
|
|
|
|
| 08/15/2003
|
| 2003V-0371
|
| ECSU Planetarium/
Elizabeth City State University/Laser Light Show
|
| APPROVED
09/10/2003
|
|
|
|
|
|
| 08/15/2003
|
| 2003P-0372
|
| CollaGenex
Pharmaceuticals/Refuse to approve any ANDA for doxycycline hyclate
capsules 20mg
|
| Denied 05/13/2005
|
|
|
| 08/18/2003
|
| 2003V-0373
|
| Eagle River
Bowl LLC./Laser Light Show
| APPROVED 11/10/2003;Terminated
11/10/2005
|
|
| 08/19/2003
|
| 2003V-0374
|
| Beaming
Man/Laser Light Show
|
| APPROVED
08/27/2003
|
|
|
| 08/20/2003
|
| 2003V-0377
|
| Wild Country/Laser
Light Show
| APPROVED 10/27/2003;
Terminates 10/27/2005
|
|
| 08/21/2003
|
| 2003V-0378
|
| Northway
Lanes/Laser Light Show
|
|
|
| 08/25/2003
|
| 1978N-0038
|
| CTFA &
CHPA/Sunscreen Drug Products
|
|
|
| 08/25/2003
|
| 2003P-0387
|
| Abbott Laboratories/Request
that the Commissioner of Food and Drug take action described
methodology for oral levothyroxine sodium drug products
| Interim Response 02/23/2004 |
|
| 08/26/2003
|
| 2003P-0398
|
| International
Regulatory Business Consultants, LLC/(ANDA) for Oral Capsule
Dosage Form Containing Hydrocodone Bitartrate 5 mg/Butalbital
50 mmg/ Cafferine 40mg/ Acetaminophen 325mg
| WITHDRAWN 11/21/2003
|
|
| 08/27/2003
|
| 2003P-0388
|
| Lachman
Consultant Services, Inc./ANDA Suitability for Metformin Hydrochloride
Extended-Release (XR) Tablets, 1000 mg
| APPROVED 12/23/2003
|
|
|
|
|
|
|
|
| 08/27/2003
|
| 2003V-0389
|
| I
T Maintenance/Laser Display Device
|
|
|
|
|
|
| 08/28/2003
|
| 2003V-0394
|
| XO/Laser
Light Show
| APPROVED 09/11/2003
|
|
|
|
|
|
|
|
| 08/28/2003
|
| 2003P-0393
|
| PharmaForce,
Inc./Diazepam Injection USP, 5 mg/mL, 1-mL,(ANDA No. 72-079),
by Abbott laboratories, Inc., has been voluntarily withdrawn
or withheld from sale for safety or efficacy reasons
| Answer 04/02/2004 |
|
| 08/28/2003
|
| 1978N-0038
|
| CTFA and
CHPA/Sunscreen Drug Products
|
|
|
|
|
|
|
|
|
|
|
| 08/28/2003
|
| 2003V-0396
|
| Kaanapali
Beach Hotel/Laser LIght Show
| APPROVED 10/02/2003;
Terminates 10/02/2005
|
|
| 08/28/2003
|
| 2003V-0395
|
| Lunar
Bowl/Laser Light Show
| APPROVED 09/11/2003
|
|
|
|
|
|
|
|
| 09/03/2003
|
| 2003P-0408
|
| TorPharm,
Inc./Request for Immediate Withdrawal of Final Approval of Syntheon's
NDA No. 21-299 for Asimia (Paroxetine Mesylate) 10 mg, 20 mg,
30 mg and 40 mg Tablets
| DENIED 10/14/2003
|
|
| 09/03/2003
|
| 2003P-0409
|
| Orthopedic
Surigical Manufacturers Assn./Reclassification for Moblie Bearing
Knees from Class III and Class II
|
|
|
| 09/04/2003
|
| 2003P-0413
|
| Lachman
Consultant Services, Inc./Hyrocodone Bitartrate and Acetaminophen
Tablet, USP 7.5 mg/300 mg combination drug product is suitable
for submision as a ANDA
|
| Closed 11/02/2004
|
|
|
|
|
|
|
|
|
| 09/04/2003
|
| 2003P-0414
|
| Lachman
Consultant Services, Inc./Hydrocondone Bitartrate and Acetaminophen
tablets 5 mg/300 mg as an ANDA
| APPROVED 11/23/2004
|
|
|
|
|
| 09/10/2003
|
| 2003V-0423
|
| Avampato
Discovery Meseum/Laser Light Show
| APPROVED 10/10/2003;
Terminates 10/10/2005
|
|
|
|
|
|
|
|
| 09/11/2003
|
| 2003V-0426
|
| Celebration
City/Laser Light Show
| APPROVED 10/02/2003;
Approved 06/08/2005; Terminated 10/02/2008; Approved
06/26/2006
|
|
|
|
|
|
|
|
| 09/12/2003
|
| 2003V-0428
|
| Cunningham
Products Resources/Laser Light Show
| Approved 11/09/2005
|
|
|
|
|
| 09/15/2003
|
| 2003V-0430
|
| Laser Magic
Productions/Laser Light Show
|
|
|
| 09/15/2003
|
| 2003V-0431
|
| Laserworks/Laser
Light Show
|
|
|
| 09/15/2003
|
| 2003V-0433
|
| Vandenberg
Community Center/Laser Light Show
| APPROVED 10/27/2003;
Terminates 10/27/2005
|
|
| 09/22/2003
|
| 2003V-0435
|
| Warner Bros.
Entertainment Inc./Laser Light Show
| Approved 01/22/2004; Terminates 01/22/2006
|
Top
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| CHRONOLOGICAL
LIST OF PETITIONS AND ADVISORY OPINIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
| Date
Filed
|
| Docket
#
|
| Name
of Petitioner/Subject Matter
|
| Disposition
|
|
|
|
|
| 09/22/2003
|
| 2003P-0436
|
| Anabolic Laboratories,
Inc./(ANDA) containing 300 mg Acetaminophen/ 5 mg Hydrocodone, 300
mg Acetaminophen/ 7.5 mg Hydrocodone, 300 mg Acetaminophen/ 10 mg
Hydrocodone
| CLOSED 10/10/2003 Petition
is incomplete as submitted
|
|
|
|
|
| 09/23/2003
|
| 2003P-0439
|
| Dominic J. Morgan/Elective
Refractive Eye Surgery with Premarket Approvals (PMAs)
|
|
|
| 09/24/2003
|
| 2003V-0440
|
| Area 54 DJ Co./Laser Light
Show
|
|
|
| 09/24/2003
|
| 2003P-0441
|
| Nabeal M. Saif, R.Ph./ANDA
suitability for metoprolol tartrate 12.5 mg tablets
| Denied 10/15/2004 |
|
| 09/24/2003
|
| 2003P-0438
|
| Russel J. Thomsen,
MD/change the regulatory status of prenatal listening devices commonly
called 'Doppler Fetoscopes' under 21 CFR 5.10
| Denied 06/14/2004 |
|
|
|
|
|
|
|
| 09/24/2003
|
| 2003P-0437
|
| Public Citizen
Litigation Group/refrain from covering the General and Plastic Surgery
Devices panel of the Medical Devices Advsory committee on 10/14/03
| Closed 01/28/2005
|
|
|
|
|
|
|
|
| 09/25/2003
|
| 2003P-0453
|
| King & Spalding LLP/Abbreviated
new drug applications (ANDAs) suitability for hydrocodone bitartrate
| Interim Response 02/04/2004
|
|
| 09/29/2003
|
| 2003V-0454
|
| CAO Group Inc./Variance
for Denlaser 800
|
|
|
| 09/29/2003
|
| 2003V-0473
|
| Carl Zeiss Jena GMBH/Variance
Laser Display Device, JENOPTIK LOS: JenLas WHiteLight; Projector
| PENDING 10/10/2003
|
|
| 09/30/2003
|
| 2003V-0459
|
| NEA Inc./Laser Light Show
|
|
|
| 10/01/2003
|
| 2003P-0460
|
| Anabolic Laboratories,
Inc./ANDA Suitability 200 mg Carisoprodol and 325 mg of Acetaminophen
combination drug product ; 200 mg Carisprodol, 325 mg Acetaminophen,
and 16 mg Codeine Phosphate drug product
|
| Interim Response 02/04/2004
|
|
|
|
|
|
| 10/01/2003
|
| 2003P-0461
|
| Anabolic Laboratories,
Inc./Abbreviation New Drug Application (ANDA) suitablility for 7.5
mg of Cyclobenzaprine HCI
| Approved 10/15/2004 |
|
|
|
|
|
|
|
| 10/02/2003
|
| 2003P-0464
|
| Lachman Consultant Services,
Inc./ANDA for Clonazepam Oral Solution
| Approved 10/18/2005
|
|
|
|
|
| 10/08/2003
|
| 2003P-0469
|
| Eugene G. Keller, R.Ph.,
FACA/ANADA Suitability for Ivermectin Hard-Chew Anthelmintic for
(non- food) Horses
| APPROVED 12/04/2003
|
|
| 10/08/2003
|
| 2003P-0477
|
| Endotec/Expedite the revocation
of determination of the application of the AIP
| Interim Response 03/26/2004
|
|
| 10/10/2003
|
| 2003P-0475
|
| International
Regulatory Business Consultants, Ltd./Drug Product containing hydrocodone
bitartrate 5 mg and acetaminophen 325 mg in liquid form oral administration
is suitable for evaluation under an ANDA
| Interim Response 02/04/2004
|
|
|
|
|
|
|
|
|
|
|
| 10/15/2003
|
| 2003P-0479
|
| The City of
Springfield, Massachusetts/Allow importation of Canadian versions
of drugs that are approved to the United States
| Denied 08/06/2004 |
|
|
|
|
| 10/15/2003
|
| 2003V-0480
|
| Laser Design Productions
Inc./Laser Light Show
| Approved 11/03/2003 Moved to 2003V-0131
|
|
| 10/15/2003
|
| 2003V-0131
|
| Laser Design Productions
Inc./Laser Light Show
| Approved 11/03/2003
|
| Top
|
|
| CHRONOLOGICAL
LIST OF PETITIONS AND ADVISORY OPINIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Date
Filed
|
| Docket
#
|
| Name
of Petitioner/Subject Matter
|
| Disposition
|
|
|
|
|
| 10/16/2003
|
| 1978N-0038
|
| Tanning Research Laboratories,
Inc./Sunscreen Drug Products
| Inerim Response 05/05/2004
|
|
| 10/16/2003
|
| 2003P-0162
|
| JM Investment Inc./Import Canadian food
products taht do not meeting labeling requirements
| pending
|
|
| 10/20/2003
|
| 2003V-0484
|
| Pulslight Co./Laser Light
Show
|
|
|
| 10/20/2003
|
| 2003V-0485
|
| DBA Posh Nightclub Lorenzo
Entertainment/Laser Light Show
|
|
|
| 10/21/2003
|
| 1997D-0411
|
| GME & GMIA/(BSE) in
Products for Human Use; Guidance for Industry.
|
|
|
| 10/23/2003
|
| 2003V-0489
|
| Discovery Beach Restaurant
& Club Inc./Laser Light Show
|
| APPROVED 11/10/2003;
Terminates 11/10/2005
|
|
|
|
|
|
| 10/24/2003
|
| 2003P-0494
|
| Baxter Healthcare
Corporation/Not approve any new drug application (NDA) for a hyaluronidase
product unless the conditions set forth in the petition are satisfied
| Deenied 05/05/2004
|
|
|
|
|
|
|
|
| 10/27/2003
|
| 2003V-0495
|
| Lasertek F/X/Laser Light
Show
|
|
|
| 10/29/2003
|
| 2003V-0500
|
| WBII TV/Projector for
a Laser Light Show
|
|
|
| 10/30/2003
|
| 2003P-0501
|
| Lachman Consultant
Services, Inc./Pyridostigmine Bromide Tablets, 30mg for the of myasthenia
gravis (ANDA) voluntarily withdrawn from sale for safety or efficacy
reasons
| Answer 06/22/2005
|
|
|
|
|
|
|
|
| 10/31/2003
|
| 2003P-0505
|
| Lachman Consultant
Services, Inc./ANDA for Acetaminophen, Caffeine and Orphenadrine
Citrate Tablets
| Withdrawn 07/07/2004 |
|
|
|
|
|
|
|
| 11/04/2003
|
| 2003V-0510
|
| InterVision/Spectra Scan
Laser Systems Cat's Meow Projector
| Approved 02/26/2004
|
|
| 11/04/2003
|
| 2003V-0514
|
| Heritage Planetarium/Laser
Light Show
|
|
|
| 11/05/2003
|
| 2003V-0515
|
| Full House Productions
L. L. C./Laser Display Device
|
|
|
| 11/05/2003
|
| 2003V-0516
|
| Vanderbilt Museum Planetarium/Laser
Light Show
|
|
|
| 11/05/2003
|
| 2003P-0517
|
| Alpharma Inc./Determine
that Pennifield is not eligible for interim marketing for bacitracin
MD
|
|
|
| 11/05/2003
|
| 2003P-0518
|
| Wyeth Pharmaceuticals/Refrain
from approving any Abbreviated New Drug Application for sirolimus
with Rapamune (sirolimus)
| Approveed 09/20/2004 |
|
|
|
|
|
|
|
| 11/06/2003
|
| 2003P-0519
|
| Abbott Laboratories/ANDA
Suitability for Ondansetron Hydrochloride Injection and Ondansetron
Hydrochloride Injection Premixed
| Withdrawn 03/22/2004
|
|
|
|
|
|
|
|
| 11/06/2003
|
| 2003P-0511
|
| Public Citizen
Health Research Group/refrain from completing the review of the
PMA submitted by Inamed Corporation(Inamed) for McGhan silicone
gel-filled breast implants
| DENIED 12/04/2003
|
|
|
|
|
| 11/10/2003
|
| 2003P-0520
|
| NUMBER NOT USED/Laser
Light Show
|
|
|
| 11/10/2003
|
| 2003V-0521
|
| Heritage Planetarium/Laser
Light Show
| Approved 12/21/2005
|
|
| 11/12/2003
|
| 2003P-0523
|
| Karen A. Sisson/ANADA
Suitability Petition for Ivermectin/Praziquantel Granule/Crumble
Anthelmintic for Horses
| APPROVED 12/04/2003
|
|
| 11/17/2003
|
| 2003V-0527
|
| Carnaval Night Club/Laser
Light Show
| APPROVED 12/15/2003
|
|
| 11/18/2003
|
| 2003P-0530
|
| Chemically Associated
Neurological Disorders/Silicone Gel-filled Breast Implants
| DENIED 12/04/2003
|
|
| 11/19/2003
|
| 2003P-0531
|
| Fulcrum Inc./Issue
a report providing the necessary information on pill weight tolerances
and/or variations caused by reformulations
| Denied 08/17/2005 |
|
|
|
|
|
|
Top
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|
| CHRONOLOGICAL
LIST OF PETITIONS AND ADVISORY OPINIONS
|
|
|
|
|
|
|
|
|
|
|
|
| Page
1
|
|
|
|
|
|
|
|
|
|
| Date
Filed
|
| Docket
#
|
| Name
of Petitioner/Subject Matter
|
| Disposition
|
|
|
|
|
| 11/21/2003
|
| 2003P-0534
|
| Lachman
Consultant Services, Inc./Glyburide and metformin hydrochloride
Oral Solution 1.25 mg/250 mg per 5 mL; 2.5 mg/500 mg per 10
| Approved 07/30/2004 |
|
|
|
|
|
|
|
| 11/25/2003
|
| 2003V-0540
|
| Colossal Mobile
Sound/Laser Light Show
| Approved 02/24/2004 |
|
| 11/26/2003
|
| 2003V-0541
|
| Crobar/Laser
Light Show
| APPROVED 12/23/2003
|
|
| 12/01/2003
|
| 2003P-0544
|
| Center for Food Safety
& Public Citizen, Critical Mass/Modify existing food additive
regulation with respect to the irradiation of ground beef byproducts
| WITHDRAWN 12/09/2003
|
|
| 12/01/2003
|
| 2003V-0543
|
| Pulse - Mobile DJ/A Projector
for a Laser Light Show
| APPROVED 12/23/2003
|
|
| 12/01/2003
|
| 1992N-0297
|
| Pharmaceutical Distributors
Association/Prescription Drug Marketing Act of 1987, Drug Amds of
1992
| Approved 03/30/2004 |
|
| 12/01/2003
|
| 1988N-0258
|
| Pharmaceutical Distributors
Association/Prescription Drug Marketing Act of 1987; Guideline
| Approved 03/30/2004
|
|
| 12/03/2003
|
| 2003N-0361
|
| Pharmaceutical Distributors
Association/Anti-Counterfeit Drug Initiative
| PENDING 12/03/2003
|
|
| 12/04/2003
|
| 2003V-0546
|
| The Ark/JGET/Laser Light
Show
| APPROVED 12/22/2003, Terminates
12/22/2005
|
|
| 12/08/2003
|
| 2003P-0548
|
| GrayCary/Determination
whether Dexamethasone Acetate Injection withdrawn for Safety Reasons
| Answered 09/23/2004
|
|
| 12/09/2003
|
| 2003V-0550
|
| Whatergy Inc./Laser Light
Show
| Approved 02/04/2004; Terminates
on 02/04/2006
|
|
| 12/09/2003
|
| 2003P-0551
|
| Alphapham Pty Ltd/Citalopram
Hydrobromide Capsules
| Approved 03/29/2005
|
|
| 12/10/2003
|
| 2003P-0555
|
| Committee for Truth in
Psychiatry/Maintain the Electroconvulsive Therapy Device in Class
III for All Indications
| Answer 09/03/2004 |
|
| 12/11/2003
|
| 2003P-0556
|
| Hyman, Phelps & McNamara,
PC/ANDA for Dihydroergotamine Mesylate Injection
| Denied 04/01/2005
|
|
| 12/12/2003
|
| 2003P-0552
|
| Jurox PTY, limited/ANADA
for a generic new animal drug caroprofen
| Approved 03/19/2004 |
|
| 12/12/2003
|
| 2003P-0530
|
| J Huffman/Silicone Gel-filled
Breast Implants
| PENDING 12/12/2003
|
|
| 12/12/2003
|
| 2003P-0479
|
| State of Vermont, Agency
of Administration/Allow importation of Canadian versions of drugs
that are approved to the United States
| Denied 08/04/2004 |
|
| 12/18/2003
|
| 2003V-0563
|
| Rowan University, Department
of Physics & Astronomy/Laser Light Show
| PENDING 12/18/2003
|
|
| 12/19/2003
|
| 2003V-0566
|
| True Lasers LLC./Laser
Light Show
| PENDING 12/19/2003
|
|
| 12/23/2003
|
| 2003P-0576
|
| Stockbridge Family Medicine/Warning
Label for all Food Products Which Contain Gluten
| Closed 05/06/2004 |
|
| 12/24/2003
|
| 2003P-0574
|
| American Bakers Association
et al/Regulatory limit for Listeria monocytogenes in ready-to-eat
foods that do not support its growth
| PENDING 12/24/2003
|
|
| 12/30/2003
|
| 2004P-0008
|
| Cancer Action NY/Protection
from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofurans
|
|
|
| 12/31/2003
|
| 2004P-0004
|
| Environmental Working
Group/Request for correction of FDA'S ''Advice for women who are
pregnant, or who might become pregnant, and nursing mothers, about
avoiding harm to your baby or young child from mercury in fish and
shellf
| PENDING 12/31/2003
|
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| 2001 | 2000
Page updated January 3, 2005 |
