 |
Chronological
List of Petitions and Advisory Opinions
From January 1 to December 31, 2002
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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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| 01/03/2002
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| 2002P-0001
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| Biovail Corporation/Curb
Abuses by Sponsors of ANDAs
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| 01/04/2002
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| 2002P-0004
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| Ambi Pharmaceuticals,
Inc./ANDA for Hydrocodone Bitartrate & Actaminophen
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| 01/10/2002
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| 2002P-0009
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| National Juice Products
Assn./Amend 21 CFR 120.24 concentrated and shelf-stable juice
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| 01/10/2002
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| 2002V-0008
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| Alpha Music Inc./Laser
light show
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| 01/11/2002
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| 2002P-0013
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| Colin G. Meyer, DVM,
PhD/Rescind GRAS Status for Aluminum-containing Food Additives
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| Denied 12/09/2004
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| 01/11/2002
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| 2002V-0015
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| Hawthorn Lanes, Inc./Laser
Light Show
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| 01/11/2002
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| 2002V-0016
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| Chase Chad, Inc./Laser
Light Show
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| 01/11/2002
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| 2002V-0017
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| Silhouette Lights
& Staging/Laser light show
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| 01/14/2002
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| 2002V-0018
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| Twilight Lighting
Systems/Laser Light Show
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| 01/15/2002
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| 2002P-0025
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| National Vaccine Information
Center/Immediate suspension all vaccine containing Thimerosal
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| Denied 08/11/2005
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| 01/16/2002
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| 2002P-0026
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| Baker Norton Pharmaceuticals,
Inc./ANDA for Paclitaxel, ANDA 75-184
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| 01/17/2002
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| 2002P-0029
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| Berlex Laboratories,
Inc. & 3M Pharmaceu/Mylan estradiol transdermal system as
generic substitute
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| Denied
10/22/2004
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| 01/18/2002
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| 2002P-0033
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| Lachman Consultant
Services, Inc./Carbidopa & Levodopa Orally Disintegrating
Tablets
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| 01/24/2002
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| 2002V-0040
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| Defiant & Film
Effects, Inc./Laser Light Show
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| 01/24/2002
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| 2002V-0041
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| Laser Wizardry East/Laser
Light Show
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| Approved 06/08/2005;
Termination date 04/09/2007
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| 01/25/2002
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| 2002P-0043
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| Michael Lisjak/Determine
Pipracil Was Withdrawn For Safety Reasons
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| 01/25/2002
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| 2002P-0045
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| Cook Biotech Incorporated/SURGISIS
Periodontal Membrane (D.C. #K010952)
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| 01/25/2002
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| 2002V-0044
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| Andy Pratt Professional
Disc Jockey/Laser Light Show
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| 01/28/2002
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| 2002V-0048
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| Musique Express/Laser
Light Show
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| 01/30/2002
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| 2002V-0050
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| Aqua Max Laser Display
Inc./Laser Light Show
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| 01/31/2002
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| 2002P-0056
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| Shotwell & Carr,
Inc., Atley Pharma/(ANDA) Suitability for butalbital and acetaminophen
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| 02/01/2002
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| 2002P-0057
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| Nephron Pharmaceuticals
Corp./Relisting of Ventolin Albuterol Sulfate Inhalation
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| 02/06/2002
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| 2002P-0059
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| Hoffmann-La Roche
Inc./Refrain from Approving ANDA for Isotretinoin Drug Products
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| 02/08/2002
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| 2002P-0061
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| SterilMed, Inc./Modify
the 2/14/02 deadline for Class II Reprocessed Devices
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| 02/08/2002
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| 2002P-0061
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| Vanguard Medical Concepts,
Inc./Modify the 2/14/02 deadline for Class II Reprocessed Devices
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| 02/11/2002
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| 2002P-0061
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| Alliance Medical Corp./Modify
the 2/14/02 deadline for Class II Reprocessed Devices
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| 02/12/2002
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| 2002P-0067
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| PCRM/All estrogen-containing
products intended for oral use
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| APPROVED 10/16/2003;Terminates
09/20/2006
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| 02/12/2002
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| 2002P-0068
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| ChymoCorp/Determination
of Chymopapain (Chymodiactin)
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| 02/12/2002
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| 2002V-0069
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| AREA 54 DJ, Co./A
projector for a laser light show
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| 02/12/2002
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| 1975N-0183H
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| Ciba Specialty Chemicals
Corporation/Health-Care Antiseptic Drug Products for OTC Human
Use
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| 02/15/2002
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| 2002P-0075
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| GlaxoSmithKline
Consumer Healthcare, LP/Flavored Candy-like Products Containing
Tobacco
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| DENIED 08/29/2003
Denied August 29, 2003
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| 02/15/2002
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| 2002V-0072
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| Hotel Devlmt-Taxas
bda Illusions Cabaret/Laser Light Show
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| 02/19/2002
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| 2002V-0074
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| J Professional
Inc, DBA Radio Interactiv/Laser Light Show
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| ANSWER 08/18/2003
Closed 08/18/2003
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| 02/20/2002
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| 1975N-0183H
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| Alcavis
International/Health-Care Antiseptic Drug Products for OTC Human
Use
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| 02/21/2002
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| 2002P-0078
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| Kleinfeld,
Kaplan & Becker/ANDA for Baclofen Orally Disintegrating
Tablets, 10 mg & 20
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| 02/22/2002
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| 2002V-0079
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| Ultrasonic
DJ Services, Inc./Laser Light Show
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| 02/26/2002
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| 2002P-0084
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| Pharmaceutical
Solutions, Inc./ANADA for a generic version of trimethoprim
& sulfadiazine c
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| 03/05/2002
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| 2002P-0089
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| St. Jude
Medical/Allow Electronic Labeling to Meet 201(m) of FD&C
Act
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| APPROVED
09/29/2003
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| 03/05/2002
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| 2002V-0087
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| Gulf Coast
Entertainment/Laser Light Show
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| 03/05/2002
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| 2002V-0088
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| Entertainment
Laser Systems/Laser Light Show
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| 03/05/2002
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| 2002V-0090
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| Powerhouse
Productions/Laser Light Show
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| 03/05/2002
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| 2002V-0091
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| Roscoe Entertaniment/Laser
Light Show
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| 03/05/2002
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| 2002V-0092
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| Poseidon,
Inc. dba Mythos/Laser Light Show
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| 03/05/2002
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| 1998N-0583
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| Sandler,
Travis & Rosenbeg, P.A./Exports: Notification and Recordkeeping
requirements
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| 03/06/2002
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| 2002V-0093
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| 4th Dimension
Laser, LLC/Laser light show
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| 03/08/2002
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| 1998N-0583
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| Consumer
Healthcare Products Association/Exports: Notification and Recordkeeping
requirements
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| 03/13/2002
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| 1998N-0583
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| CTFA/Exports:
Notification and Recordkeeping requirements
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| 03/14/2002
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| 2002P-0105
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| Lachman
Consultant Services, Inc./ANDA Suitability for Oxycodone and
Acetaminophen Tablets
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| 03/14/2002
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| 2002V-0106
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| Cathedral
of the Cross/Laser Light Show
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| 03/14/2002
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| 2002V-0107
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| Associated
Laser Productions Internal/Laser Light Show
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| 03/14/2002
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| 2002V-0108
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| FX Lasers,
Inc./Laser light show
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| 03/15/2002
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| 2002V-0110
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| Music Gladiators
Mobile Entertainment/Laser Light Show
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| 03/18/2002
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| 2002V-0111
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| Mixed Entertainment
Corporation/Laser Light Show
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| 03/20/2002
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| 2002P-0116
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| Peiser &
Associates, Inc./Sec. 480.200 Expiration Dating of Unit Dose
Repackaged Drugs
| Approved 10/28/2005
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| 03/21/2002
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| 2002V-0117
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| Intense
Lasers Inc./Laser Light Show
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| 03/22/2002
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| 2002P-0120
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| Public Citzen
Health Research Group/Request the immediate ban of Meridia (sibutramine)
| Denied 08/09/2005 |
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| 03/22/2002
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| 2002P-0122
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| CSPI/Request
Rulemaking on Functional Foods & Establish Adv. Com.
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| 03/22/2002
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| 2002V-0119
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| George W.
Long, Inc./SeaBreeze Amusement/Laser light show
| Approved 07/13/2006 |
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| 03/26/2002
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| 2002P-0127
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| PharmaForce,
Inc./Determine if Phenergan has been withdrawn or withheld from
s
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| 03/26/2002
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| 2002V-0126
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| Dynamic
Sound Lighting & Music/Laser Light Show
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| 03/26/2002
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| 2002V-0129
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| Area Nightclub,
Inc., dba DV8/Laser Light Show
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| 03/27/2002
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| 2002V-0130
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| Astro Audio
Video & Lighting, Inc./Laser light show
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| 03/27/2002
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| 2002V-0132
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| Sound Dimensions/Laser
Light Show
| Approved 03/25/2005
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| 03/28/2002
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| 2002P-0135
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| Jerome Stevens
Pharmaceuticals, Inc./Orally-Administered Levothyroxine Sodium
all NDAs & ANDAs
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| 03/28/2002
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| 2002V-0136
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| Farmland
Entertainment, Inc./laser light show
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| 03/29/2002
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| 2002P-0138
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| Lachman
Consultant Services, Inc./ANDA for Carisoprodol Orally Disintegrating
Tablets, 350mg
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| 04/02/2002
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| 2002P-0139
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| Public Citizen/Arava
(leflunomide;Aventis) remove from the market
| Denied 03/23/2004 |
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| 04/02/2002
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| 2002P-0141
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| Women First
Healthcare/ANDA for 1.2 mg estropipate (1.2 mg sodium estrone
sulfate)
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| 04/04/2002
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| 2002V-0143
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| Pacific
Laser Production/Laser Light Show
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| 04/09/2002
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| 2002V-0146
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| Electro
Magic/Laser Light Show
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| 04/09/2002
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| 1999D-0392
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| United Fishing
Agency, Ltd./Seafood HACCP transition guidance
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| Denied 09/04/2003
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| 04/10/2002
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| 2002V-0153
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| Hitachi
High-Technologies Corp. (Japan)/Laser DNA Sequencer device 3100
genetic analyzer variance.
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| 04/11/2002
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| 2002P-0148
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| Lavender
Consulting Services, Inc/ANDA for Fenofibrate Tablets (Tricor)
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| 04/12/2002
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| 2002P-0168
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| Arthur Blank/Request
better product labeling of sports & energy beverages
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| 04/12/2002
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| 2002V-0151
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| Cambridge
Lasers Laboratories/Laser light show
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| 04/15/2002
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| 2002P-0154
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| Biogen,
Inc./The Labeling of Serono's REBIF is Misleading
| Withdrawn 03/02/2007
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| 04/15/2002
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| 2002V-0154
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| Western
Starlight, Inc./Laser light show.
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| 04/15/2002
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| 1976N-0052N
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| Bayer Corporation/OTC
Nasal Decongestants
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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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| 04/15/2002
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| 1978N-0064
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| Cosmetic, Toiletry,
and Fragrance Assn./OTC Antiperspirant
| Denied 10/7/2004
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| 04/16/2002
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| 2002P-0166
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| Auishalom Klammer/Print
clear, legible & intelligible product expiration date
| Denied 12/15/2006 |
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| 04/16/2002
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| 2002V-0157
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| The Ultimate Place
2B/laser light show
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| 04/16/2002
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| 2002V-0158
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| Sorcar Engineering,
Inc./Laser Light Show
| Approved 05/17/2004
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| 04/17/2002
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| 2002P-0161
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| Lachman Consultant
Services, Inc./ANDA Suitability for Isotretinoin Capsules 30
mg
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| 04/17/2002
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| 2002P-0163
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| WellPoint Health Networks/Expedite
Over-the-Counter Approval for Desloratidine
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| 04/17/2002
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| 2002V-0162
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| Metropolitan Opera
Association/Laser light show
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| 04/18/2002
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| 2002V-0165
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| Eyelusions/Laser Light
Show
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| 04/19/2002
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| 2002P-0177
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| Arla Foods Ingredients
amba/Health Claim: D-tagatose and Noncariogenicity
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| 04/22/2002
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| 2002P-0170
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| Amarin Pharmaceuticals,
Inc./ANDAs relaying Permax as reference listed drug not be appove
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| 04/22/2002
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| 2002P-0176
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| Strasser & YDE,S.C./Pesticide
chemical residue Pentochloronitrobenzene (PCNB)
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| 04/22/2002
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| 2002V-0175
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| Joey's Nightclub/Laser
Light Show
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| 04/24/2002
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| 2002V-0186
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| SRO Club/Laser Light
Show
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| 04/25/2002
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| 2002V-0182
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| Vision/MCS (Memphis
Concert Sound)/Laser light show
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| 04/25/2002
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| 2002V-0183
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| Funzalosound/Laser
Light Show
| Approved 07/13/2006 |
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| 04/26/2002
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| 2002V-0185
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| Creative Teen Concepts,
Inc Club 17/Laser Light Show
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| 04/30/2002
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| 2002P-0187
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| Hako-Med/Exemption
of any connector in lead having a conductive conne
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| 04/30/2002
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| 2002P-0189
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| Phoenix Scientific,
Inc./Physical form of drug product in to a oral liquid generic
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| 04/30/2002
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| 2002P-0191
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| Teva Pharmaceuticals
USA, Inc./Request for immediate final approval of tramadol Hydrochlori
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| 04/30/2002
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| 2002V-0188
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| Shore Lanes, Inc./Laser
Light Show
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| 04/30/2002
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| 2002V-0190
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| Isorad Ltd./X-Ray
Fluoroscopic Inspection Systems - SDS 400/S & P
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| 04/30/2002
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| 2002V-0192
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| Riverband Community
Church/Laser Light Show
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| 04/30/2002
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| 2002V-0193
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| Quark Lighting Technology/Laser
Light Show
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| 04/30/2002
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| 2002V-0194
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| Rauch Planetarium/Laser
Light Show
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| 05/01/2002
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| 2002V-0195
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| Tinseltown/Laser light
show
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| 05/01/2002
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| 2002V-0196
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| Pure - Torbati Enterprises/Laser
Light Show
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| 05/03/2002
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| 2002P-0198
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| Richdel, Inc./ANADA
for ivermectin having a different dosage form (oral ge
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| 05/03/2002
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| 2002V-0197
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| TKO Sound/Laser Light
Show
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| 05/06/2002
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| 2002P-0205
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| Society Research on
Nicotine and Tobacco/SRNT petition to regulate Ariva tobacco
lozenges
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| 05/06/2002
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| 2002P-0206
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| Society Research Nicotine
and Tobacco/SRNT to regulate Omni and Adance cigarettes
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| 05/06/2002
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| 2002V-0201
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| AV-Pro Inc./Laser
Light Show
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| 05/06/2002
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| 2002V-0202
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| Digital Jamz/Laser
Light Show and Projector
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| 05/06/2002
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| 2002P-0207
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| Society Research Nicotine
and Tobacco/SRNT petition to regulate SF Garrett's Nicotine
Water
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| 05/07/2002
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| 2002V-0210
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| Michell Sales/laser
light show
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| 05/08/2002
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| 2002P-0211
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| American Environmental
Safety Institute/Amend 21CFR163,"Cacao Products: Stds of
Identity"
| Denied 4/18/2006
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| 05/08/2002
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| 2002P-0212
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| American
Environmental Safety Institute/Lead & Cadmium Levels Permitted
in Cocoa/Applicable Standard
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| 05/08/2002
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| 2002V-0213
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| PegLeg Entertainment/Laser
Light Show
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| 05/08/2002
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| 2002V-0214
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| Andrus Laser Research/Laser
Light Show
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| 05/09/2002
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| 2002P-0219
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| Altana Inc./Amend
the "Orange Book" for Fluocinide Emulsified Base
| Approved 8/20/2003
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| 05/13/2002
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| 2002V-0221
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| Choctaw Resort Development
Enterprise/Laser Light Show
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| 05/13/2002
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| 2002V-0222
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| Laser Energy/Projector
for Q-Bean Series
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| 05/14/2002
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| 2002V-0223
|
| Us and Them/Laser
Light Show
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| 05/14/2002
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| 2002V-0224
|
| Q-Peak, Inc./Laser
Light Show
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|
| 05/15/2002
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| 2002P-0225
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| Lachman Consultant
Services, Inc./ANDA for Levorphanol Tartrate Tablets
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| 05/15/2002
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| 1975N-0183H
|
| Lonza, Inc./Health-Care
Antiseptic Drug Products for OTC Human Use
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| 05/17/2002
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| 2002P-0226
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| Kirkpatrick &
Lockhart LLP/ANDA for methotrexate sodium oral solution, 5mg/ml
| Approved 10/06/2003
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| 05/17/2002
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| 2002V-0227
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| CHT Systems/Laser
light show
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| 05/20/2002
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| 2002V-0229
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| East Providence Lanes/Laser
light show
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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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| 05/20/2002
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| 2002V-0230
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| Montgomery
County Memorial Hall/Laser Light Show, Laser Fantasy International-Rainbow
I Proj
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| 05/21/2002
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| 2002P-0233
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| Kleinfeld,
Kaplan and Backer/Hydrocodone Bitartrate/Acetaminophen orally
5mg/500mg ANDA
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| 05/21/2002
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| 2002V-0234
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| Texas Steak
House dba Celebrations/Laser light show
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| 05/22/2002
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| 2002V-0238
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| Long Island
Laser Works/Laser Light Show
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| 05/22/2002
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| 2002V-0239
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| Spellbound
Productions/Laser Light Show
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| 05/22/2002
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| 2002V-0240
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| Lazerus
Laser Systems/Laser Light Show
| APPROVED 03/22/2005
|
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| 05/28/2002
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| 2002P-0243
|
| Julian M.
Whitaker, M.D./Require Issuance of Medication Guide for All
Statin Drugs
| Denied 03/04/2005
|
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| 05/28/2002
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| 2002P-0244
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| Dr. Julian
M. Whitaker, M.D./Warning Statement for All HMG Co-A Reductase
Inhibitors
| Denied 03/04/2005
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| 05/29/2002
|
| 2002P-0245
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| Gensia Sicor
Pharmaceuticals, Inc./ANDA for Fludarabine Phosphate Injection,
25 mg/ML
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| 05/30/2002
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| 2002P-0247
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| AAC Consulting
Group/ANDA Suitability for Clozapine 50 mg Tablets
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| 05/30/2002
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| 2002P-0249
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| AAC Consulting
Group/ANDA for 7.5 mg Mirtazapine Tablets
|
|
|
| 05/30/2002
|
| 2002V-0248
|
| Princeton
Alliance Church/Laser Light Show
|
|
|
| 05/31/2002
|
| 2002P-0252
|
| Caraco Pharms
Labs, Ltd./Seek immediate final approval of generic tramadol
hydrochlor
|
|
|
| 06/03/2002
|
| 2002P-0256
|
| Mylan Pharmaceuticals,
Inc./Determine if ANDA 76-122 is Entitled to 180 Days Exclusivity
|
|
|
| 06/03/2002
|
| 2002P-0294
|
| Orthopedic
Surgical Manufacturers Assn/Polymethylmethacrylate (PMMA) Bone
Cement
|
|
|
| 06/04/2002
|
| 2002P-0246
|
| University
of Colorado Hospital/Pharmacies of hospitals/other health care
entities
|
|
|
| 06/05/2002
|
| 2002V-0262
|
| Creative
Lighting and Sound/Laser Light Show
|
|
|
| 06/06/2002
|
| 2002V-0261
|
| Acme Corp
Production Services/Laser Light Show
|
|
|
| 06/06/2002
|
| 2002V-0265
|
| Canobie
Lake Park/Laser Light Show
| Approved 06/08/2005; Termination date 03/12/2008
|
|
| 06/07/2002
|
| 2002V-0263
|
| Disneyland
Resort/Laser Light Show
|
|
|
| 06/11/2002
|
| 2002V-0269
|
| Telexport,
Inc. (TEI)/Laser light show
|
|
|
| 06/11/2002
|
| 1978N-0036L
|
| American
Herbal Products Assn. & etc./OTC Laxative
|
| DENIED 07/03/2003
|
|
|
| 06/12/2002
|
| 2002P-0267
|
| Nocona General
Hospital/Amend Mammography Quality Standards Act & FOIA
| Approved
and Denied in Part 10/21/2003
|
|
| 06/13/2002
|
| 2002P-0270
|
| SciRegs/Suitability
Petition for Hydrocodone Bitartrate/Ibuprofen 5
|
|
|
| 06/17/2002
|
| 2002V-0279
|
| Daamini/Laser
light show
|
|
|
| 06/17/2002
|
| 1998N-0583
|
| Grocery
Manufacturers of America & CTFA/Exports: Notification and
Recordkeeping requirements
|
|
|
| 06/20/2002
|
| 2002V-0287
|
| Integrated
Production Systems, Inc./Laser light show
|
|
|
| 06/21/2002
|
| 2002P-0292
|
| California
Walnut Commission/Health Claims: Walnuts & Cornary Disease
| Answer 03/09/2004 |
|
| 06/21/2002
|
| 2002V-0283
|
| International
Laser and Light, Inc./Laser Light Show
|
|
|
| 06/21/2002
|
| 2002V-0293
|
| Tuco Innovations,
Inc./Erchonia Low-Level Laser Device
|
|
|
| 06/24/2002
|
| 2002P-0285
|
| King &
Spalding/Combination oxycodone hydrochloride/acetaminophen tablet
|
|
|
| 06/24/2002
|
| 2002V-0300
|
| Valentino/Laser
light show
|
|
|
| 06/25/2002
|
| 2002V-0286
|
| Adams Audio
Labs. Laser Div./Laser light show
|
|
|
| 06/27/2002
|
| 2001P-0495
|
| Ortho-McNeil/Determine
Ultram's safety or effectiveness reasons
|
|
|
| 06/27/2002
|
| 2002P-0191
|
| Ortho-McNeil/Request
for immediate final approval of tramadol Hydrochlori
|
|
|
| 06/27/2002
|
| 2002P-0252
|
| Ortho-McNeil/Seek
immediate final approval of generic tramadol hydrochlor
|
|
|
| 06/28/2002
|
| 2002P-0297
|
| Lachman
Consultant Services, Inc./ANDA for Propoxyphene Hydrochloride,
Acetaminophen&Caffeine
|
|
|
| 07/01/2002
|
| 2002V-0301
|
| Counter
Clockwise Productions Inc./Laser Light Show
|
|
|
| 07/02/2002
|
| 2002V-0304
|
| Valentino/Laser
Light Show
|
|
|
| 07/10/2002
|
| 2002P-0312
|
| CollaGenex
Pharmaceuticals, Inc./Periostat (doxycycline hyclate) 20 mg
Capsules
| Answered 05/16/2005
|
|
| 07/10/2002
|
| 2002P-0312
|
| CollaGenex
Pharmaceuticals, Inc./Periostat (doxycycline hyclate) 20 mg
Capsules
| Answered 05/16/2005
|
|
| 07/16/2002
|
| 2002P-0317
|
| Mission
Possible International/Recall Aspartame as a Neurotoxic Drug
|
|
|
| 07/16/2002
|
| 2002V-0318
|
| Laser Image/Laser
Light Show
|
|
|
| 07/19/2002
|
| 2002P-0321
|
| Miami Crab
Corporation/Grant relief unwarranted testing for chloramphenicol
crabmea
|
| DENIED 07/29/2003
|
|
|
| 07/22/2002
|
| 2002V-0323
|
| The Hamlet
on Olde Oyster Bay/Laser Light Show
|
|
|
| 07/24/2002
|
| 2001E-0363
|
| Corcept
Therapeutics Inc./Patent Term Extension Application, MIFEPREX
No. 4,386,085
|
|
|
| 07/25/2002
|
| 2002V-0328
|
| East Coast
Entertainment, Inc./Laser light show
|
|
|
| 07/26/2002
|
| 2002V-0331
|
| Vinyl Circus/laser
light show
|
|
|
| 07/26/2002
|
| 1978N-0038
|
| CTFA &
CHPA/Sunscreen Drug Products
|
| DENIED 06/03/2003
Denied 06/03/2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Page
36
|
|
|
|
|
|
|
|
|
|
| Date
Filed
|
| Docket
#
|
| Name
of Petitioner/Subject Matter
|
| Disposition
|
|
|
|
|
| 07/29/2002
|
| 2002V-0334
|
| Solavanti,
L.L.C. DBA Contour/Laser Light Show
|
|
|
| 07/31/2002
|
| 2002P-0338
|
| Russel J.
Thomsen, MD/OTC sales, distribution all brands of hand-held
doppler fet
| Denied 06/19/2003
|
|
| 08/01/2002
|
| 2002P-0346
|
| Gensia Sicor
Pharmaceuticals/ANDA Amiodarone Hydrochloride Injection 450mg/9ml
single use
|
|
|
| 08/02/2002
|
| 2002V-0347
|
| Technological
Artisans, Inc./Laser light show
|
|
|
| 08/05/2002
|
| 2002P-0349
|
| Clasen Immunotherapies,
Inc./Amend product insert and/or label for Hemophilus Vaccines
|
| DENIED 06/26/2003
|
|
|
| 08/06/2002
|
| 2002V-0351
|
| Tour &
Concert Associates/Laser Light Show
|
|
|
| 08/08/2002
|
| 2002P-0357
|
| Bayer Corporation/Stay
Effective Date of Compliance for Monograph Title Change
|
| APPROVED
06/03/2003
|
|
|
| 08/08/2002
|
| 2002V-0356
|
| 50 Liberty
Pole Way, Inc. dba Gotham Cit/Laser light show
|
|
|
| 08/09/2002
|
| 2002P-0358
|
| The Weinberg
Group Inc./ANDA for amoxicillin tabs for oral suspension 300
& 600mg
|
|
|
| 08/12/2002
|
| 2002P-0360
|
| J. B. Proveedores
S.A. DE C./Chemical Cleaning Products for Industrial Food
|
|
|
| 08/13/2002
|
| 2002P-0363
|
| Merck Research
Laboratories/NDA 20-560: Fosamax (Alendronate Sodium Tablets)
|
|
|
| 08/13/2002
|
| 2002V-0364
|
| Laser Devices,
Inc./Variance Application for Infrared Laser Aiming Devices
|
|
|
| 08/13/2002
|
| 2002V-0365
|
| Resonant
Productions, Inc./Laser Light Show
|
|
|
| 08/13/2002
|
| 2002V-0366
|
| The Sound
Council/Laser light show
|
|
|
| 08/15/2002
|
| 2002P-0367
|
| West-Ward
Pharmaceutical Corp./Doxycycline hyclate capsules 20mg,Periostat
capsules,20mg
| Answered 05/16/2005
|
|
| 08/15/2002
|
| 2002V-0373
|
| Beaming
Man/Laser Light Show
|
|
|
| 08/15/2002
|
| 2002V-0375
|
| Nimar, Inc./Redline
lasers beambox/Redline lasers beamscan XYR-1000
|
|
|
| 08/15/2002
|
| 1978N-0036L
|
| Banner Pharmacaps,
Inc./OTC Laxative
| Denied 11/17/2003
|
|
| 08/16/2002
|
| 2002V-0432
|
| IVP Integrated
Vision Products AB/Variance for Laser Triangulation Measurement
System
|
|
|
| 08/19/2002
|
| 2002P-0374
|
| Boston University
School of Medicine/Angiotensin Converting Enzyme inhibitors
a Black Box warning
|
|
|
| 08/19/2002
|
| 2002P-0378
|
| Plantetary
Health, Inc./Genetically Engineered Rice, Wheat, and other Essential
Food
|
|
|
| 08/20/2002
|
| 2002P-0377
|
| Am Assn
of Pro Life Obstetrician & Gyn/Petition Requesting Stay
of Approval of Mifeprex
| Interim
Response 04/16/2003 |
|
| 08/20/2002
|
| 2002V-0376
|
| Jewish DJ
Service, Inc./Laser light show
|
|
|
| 08/21/2002
|
| 2002A-0379
|
| SG&A
Consulting, Inc./Device classification resulting manufacturer
for image techn
|
|
|
| 08/22/2002
|
| 2002P-0380
|
| Banner Pharmacaps/Abbreviated
New Drug Application (ANDA) for Loperamide Hydro
| Interim
Response 02/03/2004
|
|
| 08/22/2002
|
| 2002P-0424
|
| Banner Pharmacaps
Inc./ANDA for Loperamide Hydrochloride 1 mg Soft Gelatin Capsules
|
|
|
| 08/23/2002
|
| 2002V-0382
|
| Laser Devices,
Inc./Infrared Laser Aiming Devices
|
|
|
| 08/26/2002
|
| 2002P-0386
|
| Pharmaceutical
Associates, Inc/Abbreviated new drug application (ANDA)7.5 mg
hydrocodone
|
|
|
| 08/27/2002
|
| 2002V-0387
|
| Sacramento
Theatrical Lighting/Laser Light Show
|
|
|
| 08/30/2002
|
| 2002P-0390
|
| number not
used/Number not used
|
|
|
| 09/03/2002
|
| 2002P-0391
|
| IVAX Pharmaceuticals
Inc./Determine Whether Alphagan has been Voluntarily Withdrawn
| Answer 06/19/2003
|
|
| 09/03/2002
|
| 2002P-0392
|
| Barr Laboratories,
Inc./Determine Whether Ortho-Tri-Cyclen-21 has been Voluntarily
|
|
|
| 09/03/2002
|
| 2002P-0395
|
| Barr Laboratories,
Inc./Determine whether Ortho-Cyclen-21 Tablets,NDA 19 652 have
|
|
|
| 09/04/2002
|
| 2002P-0394
|
| Taro Research
Institute Ltd./Make determination of ANDA suitability for Amiodarone
Hydroc
|
|
|
| 09/04/2002
|
| 1978N-0036L
|
| Arnall Golden
Gregory LLP/OTC Laxative
|
| DENIED 09/02/2003
|
|
|
| 09/05/2002
|
| 2001E-0365
|
| Dr. Reddy's
Laboratories, Ltd./Patent Term Extension Application, NEXIUM
4,738,974
| Withdrawn 01/09/2007
|
|
| 09/05/2002
|
| 2002P-0396
|
| Intervet
Inc./Suitability Petition for Ivermectin Soft-Chew Anthelmintic
|
|
|
| 09/05/2002
|
| 2002P-0399
|
| Barr Laboratories,
Inc./Determine Whether Estrostep 21 Tablets, NDA 020130 Have
Been
| Closed 05/23/2007 |
|
| 09/05/2002
|
| 2002P-0400
|
| Barr Laboratories/Determine
Whether Niaspan Tablets, NDA 020381 Have Been
|
|
|
| 09/05/2002
|
| 2002P-0401
|
| Paddock
Laboratories, Inc./Ammonium Lactate 12% lotion and cream for
relevant
|
|
|
| 09/05/2002
|
| 2002V-0397
|
| Light and
Sound Consultants/Laser Light Show
|
|
|
| 09/05/2002
|
| 2002V-0398
|
| Otherland
Group, dba Xenoline.com/Laser Light Show
|
|
|
| 09/06/2002
|
| 2002P-0404
|
| Alcon Research,
Ltd./Determination re: Withdraw of ALPHAGAN
| Answer 06/19/2003
|
|
| 09/10/2002
|
| 2002P-0406
|
| The Weinberg
Group Inc./ANDA Suitability for Amoxicillin & Clavulanate
Potassium
| Denied 10/15/2004 |
|
| 09/11/2002
|
| 2002V-0408
|
| Classic
Computers, Inc./Laser Light Show
|
|
|
| 09/12/2002
|
| 2002V-0410
|
| Richards
Audio Visual/Variance for Q-Beam Series
|
|
|
| 09/12/2002
|
| 2002V-0411
|
| Live Bait/Laser
light show
|
|
|
| 09/13/2002
|
| 2002P-0413
|
| Kyl Smith,
D.C./Health Claim: Phosphatidylserine and cognitive dysfunction
|
|
|
| 09/16/2002
|
| 2002P-0414
|
| The Weinberg
Group Inc./Cefuroxime Axetil Tablets Oral suspension 125mg &
250mg ANDA
| Interim
Response 02/03/2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Page
37
|
|
|
|
|
|
|
|
|
|
| Date
Filed
|
| Docket
#
|
| Name
of Petitioner/Subject Matter
|
| Disposition
|
|
|
|
|
| 09/17/2002
|
| 2002V-0415
|
| Norwood
Abbey Limited/LAD-01 Medical Laser Product
|
|
|
| 09/18/2002
|
| 2002P-0416
|
| Highland
VetPharma, LLC/ANADA dosage form which differs for Ivermectin
Equalan Paste
|
|
|
| 09/23/2002
|
| 2002V-0420
|
| Lasergrace
Inc./Laser light show
| Approved 06/08/2005; Termination date 02/28/2008
|
|
| 09/24/2002
|
| 2002P-0419
|
| Bioniche
Pharma Group Limited/Amiodarone Hydrochloride Injection 50mg/mL
|
|
|
| 09/24/2002
|
| 2002P-0422
|
| Frommer
Lawrence & Haug, LLP/Propoxyphene Napsylate and Acetaminophen
100mg/35mg and 100m
|
|
|
|
|
|
|
|
|
| 09/26/2002
|
| 2002P-0423
|
| Highland
VetPharma, LLC/ANADA for ivermectin/pyrantel different dosage
form (molded,
|
|
|
| 09/27/2002
|
| 2002V-0425
|
| MGM Grand
Hotel/Laser Light Show
| ANSWER 10/31/2003
|
|
| 09/30/2002
|
| 2002P-0426
|
| Andrx Pharmaceuitcals,
Inc./Andrx in its currently pending ANDA 76-159 Glipizide product
|
| Withdrawn
02/06/2007
|
|
|
| 09/30/2002
|
| 2002P-0429
|
| Highland
VetPharma, LLC./Abbreviated new animal drug applicationIvermectin
for cats
|
|
|
| 10/01/2002
|
| 2002P-0431
|
| Arent Fox
Attorneys At Law/Delcobese Tablets and Capsules
| Answered 11/13/03 |
|
| 10/02/2002
|
| 2002P-0435
|
| Aventis
Behring, LLC/Effective Approval of Alphanate Antihemophilic
Factor
|
|
|
| 10/02/2002
|
| 2002V-0433
|
| Radio Interactive/Laser
light show
|
|
|
| 10/03/2002
|
| 2002P-0435
|
| Aventis
Behring, LLC/Effective Approval of Alphanate Antihemophilic
Factor
| Withdrawn 04/27/2006 |
|
| 10/03/2002
|
| 2002P-0436
|
| BioPartners
GmbH/ANDA for ribavirin, USP in a water soluble film-coated
table
|
|
|
| 10/07/2002
|
| 2002P-0462
|
| Carbolite
Foods, Inc./Use of Implied Nutrient Content Claim - "Carbolite"
|
|
|
| 10/08/2002
|
| 2002P-0437
|
| Richard
A. Stolworthy/Protect patients & consumers in U.S. by amending
the 510(k)
|
|
|
| 10/08/2002
|
| 2002P-0438
|
| Jarrow Formulas,
Inc./Warning on Labeling of Kava Dietary Supplements
|
|
|
| 10/09/2002
|
| 2002P-0440
|
| CSPI/Establish
a Microbial Testing Program for Hazards in Seafood
|
|
|
| 10/10/2002
|
| 2002V-0442
|
| Abracadbra
Lights & Sounds/Laser Light Show
|
|
|
| 10/11/2002
|
| 2002P-0444
|
| The Weinberg
Group Inc./cefpodoxime Proxetil talbets for Oral suspension
50mg/100mg
| Interim Response 02/03/2004 |
|
| 10/15/2002
|
| 2001M-0210
|
| The TMJ
Association/P000035;TMJ Fossa-Eminence Prosthesis
|
|
|
| 10/15/2002
|
| 2002P-0446
|
| Mechanical
Servants, Inc./Establish guidance re: "inner package"
Convenience size drug
|
| INTERIM
RESPONSE 05/15/2003 Int: 5/15/03
|
|
|
| 10/15/2002
|
| 2002P-0447
|
| Pfizer Inc./Immediately
revoke its acceptance for NDA 21-435 for amlodin
| Denied 10/14/2003
|
|
| 10/15/2002
|
| 2002P-0448
|
| SensorMedics
Corporation/ANDA Sutability for Albuterol Base Inhalation Solution
| Denied 12/17/2003
|
|
| 10/16/2002
|
| 2002P-0450
|
| B. Braun
Medical Inc./Withhold Approval of ANDA for Amino Acid Solution
Drug Prod.
|
| DENIED 06/19/2003
Denied 6/19/2003
|
|
|
| 10/17/2002
|
| 2001V-0110
|
| OmniSistem
Lights Effects/Laser Light Show
|
|
|
| 10/17/2002
|
| 2002V-0453
|
| Optical
Magic/Laser Light Show
| Approved 4/17/2006
|
|
| 10/17/2002
|
| 2002V-0455
|
| OmniSistem
Lights and Effects/Laser Light Show
|
|
|
| 10/18/2002
|
| 2002P-0457
|
| Wellness
Lifestyles, Inc./Selenium and Anticarcinogenic effects in certain
cancers
|
|
|
| 10/21/2002
|
| 2002P-0459
|
| Lachman
Consultant Services Inc./Abbreviated new drug application(ANDA)
for Metoprolol tartrt
|
|
|
| 10/21/2002
|
| 2002P-0460
|
| Caraco Pharmaceutical
Labs., Ltd./25 mg metoprolol tartrate tablets drug product of
ANDA
|
|
|
| 10/21/2002
|
| 2002V-0458
|
| Columbia
DJ Supply/Laser Light Show
|
|
|
| 10/22/2002
|
| 2002P-0464
|
| PCH Integrated
Regulatory Services, Inc./ DES 1.0 mg & 5.0 mg
|
| INTERIM
RESPONSE 06/11/2003 Int: 6/11/03;LET1
|
|
|
|
|
|
|
|
|
| 10/22/2002
|
| 2002P-0465
|
| Lachman
Consultant Services, Inc./ANDA Suitability for Oxycodone &
Acetaminophen Tablets
|
|
|
| 10/25/2002
|
| 2002P-0470
|
| Karen A.
Sisson/Change Dosgae Form of Eqvalan Paste 1.87% From Paste
to Gran
|
|
|
| 10/25/2002
|
| 2002P-0494
|
| Sirona Dental
Systems, GmbH/CEREC Ceramic Dental Restoration Systems
|
|
|
| 10/28/2002
|
| 2002P-0469
|
| Allergan,
Inc./ANDA for Brimonidine Tartrate Ophthalmic Solution 0.2%
|
| DENIED 05/21/2003
Denied 5/21/03
|
|
|
| 10/30/2002
|
| 2002P-0472
|
| Dr. Frank
I. Marcus/Petition to Post Statement in Response to Warning
Letter
| Approved and Denied in part 10/21/2003
|
|
| 10/31/2002
|
| 2002P-0473
|
| Banner Pharmacaps/ANDA
for Naproxen Sodium, 220mg (equivalent to 200 mg Naprox
|
|
|
| 10/31/2002
|
| 2002P-0474
|
| Phoenix
Scientific, Inc./ANADA for tiamulin soluble powder tiamulin
hydrogen fumarate
|
|
|
| 11/04/2002
|
| 2002V-0477
|
| Omicron
Laserage Laserprodukte GmbH/Laser Light Show
|
|
|
| 11/05/2002
|
| 2002P-0478
|
| Lachman
Consultant Services, Inc./Fentanyl transdermal system 12.5 mcg/hr
is suitable for ANDA
| Withdrawn 10/14/03 |
|
| 11/06/2002
|
| 2002P-0479
|
| CorePharma,
LLC/Cyproheptadine Hydrochloride Tablets;Assign a (RLD) status
|
| INTERIM
RESPONSE 05/28/2003 Int: 5/28/03
|
|
|
| APPROVED
05/28/2003 Approved 68FR 31720 05/28/2003
|
|
|
|
|
|
|
|
|
| 11/07/2002
|
| 2002P-0480
|
| Bioniche
Pharma Group Limited/Amiodarone Hydrochloride Injection , 50mg/mL,9mL
vial
|
|
|
| 11/08/2002
|
| 1988N-0258
|
| Pharmaceutical
Distributors Association/Prescription Drug Marketing Act of
1987; Guideline
|
|
|
| 11/08/2002
|
| 1992N-0297
|
| Pharmaceutical Distributors
Association/Prescription Drug Marketing Act of 1987, Drug Amds
of 1992
|
|
|
| 11/12/2002
|
| 2002V-0482
|
| Sonic Wave/Laser Light
Show
|
|
|
| 11/12/2002
|
| 2002P-0481
|
| Lachman Consultant
Services, Inc/Methadone Hydrochloride Tablets, USP, 15mg, 20mg
and 30(ANDA
|
|
|
| 11/13/2002
|
| 2002P-0483
|
| Kirkpatrick &
Lockhart, LLP et al/Actions re: exceptive drug products, ex
release guaifenesin
|
|
|
| 11/14/2002
|
| 2002P-0484
|
| Lachman Consultant
Services, Inc./ANDA for Amiodarone Hydrochloride Injection 50
mg/mL
|
|
|
| 11/14/2002
|
| 2002V-0485
|
| Twilight Lighting
Systems/Laser Light Show
|
|
|
| 11/15/2002
|
| 2002V-0488
|
| N/A Private Residence/Laser
Light Show
| Approved 11/10/03 |
|
| 11/18/2002
|
| 2002P-0489
|
| James H. Schafer,
D.V.M./Request Revision of CVM's Bioequivalence Guidelines
| INTERIM RESPONSE 05/15/2003
Denied 12/31/2003 |
|
| 11/18/2002
|
| 2002P-0490
|
| Number not used See
02P-0469 C1/Alphagan 0.2% was withdrawn from sale for reasons
other
|
|
|
| 11/21/2002
|
| 2002P-0493
|
| Andrx Pharmaceuticals
Corp./Anti-heart burn drug Omeprazole magnesium (brand Prilosec1)
| Denied 01/21/2005
|
|
| 11/22/2002
|
| 2002V-0495
|
| Classic Computes Inc./Laser
Light Show
|
|
|
| 11/26/2002
|
| 2002P-0498
|
| Taro Pharmaceuticals/ANDA
Warfarin Sodium Tablets, USP 0.5 mg. (Coumadin tablets)
|
|
|
| 11/26/2002
|
| 2002V-0497
|
| Penguin Promotions/Laser
light show
|
|
|
| 11/27/2002
|
| 2002P-0499
|
| The Weinberg Group
Inc./ANDA Suitability for Metformin Hydrochloride Tablets Oral
So
| APPROVED 05/14/2003
Closed 5/14/03
|
|
| 12/03/2002
|
| 2002V-0502
|
| Cell Robotics, Inc./Variance
Request for the Ultra-Light Laser System
|
|
|
| 12/04/2002
|
| 2002P-0503
|
| Roxane Laboratories/ANDA
abbreviated new drug application for Digoxin Elixir
|
|
|
| 12/04/2002
|
| 2002V-0504
|
| Swinomish Northern
Lights Casino/Laser Light Show
|
|
|
| 12/05/2002
|
| 2002P-0505
|
| International Tree
Nut Council Nutrition/Labeling nuts & eligible nut containing
products reduce risk
|
|
|
| 12/06/2002
|
| 2002P-0506
|
| Lachman Consultant
Services, Inc./Was Wydase (Hyaluronidase) Inj. withdrawn for
Safety Reasons
|
|
|
| 12/06/2002
|
| 2002V-0507
|
| Bear Productions/Laser
Light Show
|
|
|
| 12/06/2002
|
| 2002V-0508
|
| Kentwig Lanes Bowling
Center/Variance for Q-Beam Series, Projectors
|
|
|
| 12/11/2002
|
| 2002V-0512
|
| Space Based Lasers/Laser
Light Show
|
|
|
| 12/13/2002
|
| 2002V-0513
|
| Xtremo Sound/Laser
light show
|
|
|
| 12/16/2002
|
| 2002V-0517
|
| Psyteknology/Laser
Light Show
| Approved 05/04/2006
|
|
| 12/17/2002
|
| 2002P-0520
|
| Bicon, Inc./Reclassification
of Beta-Tricalcium Phosphate,
|
|
|
| 12/17/2002
|
| 2002V-0523
|
| Louisiana Arts and
Science Museum/Laser Light Show
|
|
|
| 12/17/2002
|
| 2002V-0524
|
| Central Texas College/Laser
Light Show
|
|
|
| 12/17/2002
|
| 1980N-0042
|
| Tom's of Maineer Consumer
Healthcare/Anticaries Drug Products for OTC Human Use
|
|
|
| 12/18/2002
|
| 2002V-0522
|
| Black Bear Jamboree/Laser
Light Show
|
|
|
| 12/18/2002
|
| 2002V-0521
|
| White Star/Laser Light
Show
| Approved
05/24/2006 |
|
| 12/23/2002
|
| 2002V-0533
|
| Laser Envy/Laser Light
Show and Projector
|
|
|
| 12/24/2002
|
| 2002V-0530
|
| Chat Radio Inc./Club
Matrix/Laser Light Show Projector
|
|
|
| 12/27/2002
|
| 2002V-0531
|
| Showtrends, Inc./Laser
Light Show
|
|
Updated
June 4, 2007
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