Interim Response is not a final decision on the petition.
| Date Filed
|
Docket # |
|
Name of Petitioner/Subject Matter
|
Disposition |
| Januuary |
|
|
|
|
| 01/03/2001 |
01P-0003 |
|
DRS OPTRONICS, INC / Application for Exemption Laser Products
Performance Standard |
Pending |
| 01/09/2001 |
01P-0010 |
|
Lawrence D. Bernhardt & Arnold Liebman / The Use of Cardura
for the Treatment of Hypertension |
Interim Response 06/22/2001 |
| 01/12/2001 |
01P-0028 |
|
Taro Research Institute / Chewable Tegretol Tablets |
APPROVED 5/8/01 (Closed) |
| 01/17/2001 |
80N-0146 |
|
Oakhurst Co / Nailbiting & Thumbsucking Deterrent Drug Product
for OTC Use |
Closed per telecon 02/01/2004 |
| 01/19/2001 |
01P-0034 |
|
Ruth Armstrong / Restaurant Foods Containing Methylcellulose or
Carrageenin |
Pending |
| 01/23/2001 |
01P-0036 |
|
Venable / Carboplatin Injection 10 mg / mL in a ready-to-use solution
|
Approved 11/30/2001 |
| 01/26/2001 |
01P-0045 |
|
Bimeda Inc. / Lincomycin-Spectinomycin Water Soluble Powder |
Approved 04/20/2001 |
| February |
Top |
|
|
|
| 02/02/2001 |
01P-0061 |
|
Tom Stothoff / Request to file an ANDA for Ifosfamide for Injection
|
N 67FR34457 05/14/2002 |
| 02/06/2001 |
01P-0066 |
|
First Priority, Inc. / ANADA which differs in dosage form from
innovator product |
Approved 04/09/2001 |
| 02/08/2001 |
01P-0068 |
|
Medicap Ltd. (Italy) / Revoke the ban set on implementation of
prosthetic hair fibers |
Denied 09/07/2001 |
| 02/12/2001 |
01V-0071 |
|
Rauch Planetarium/Laser Light Show |
Approved 04/17/2006 |
| 02/14/2001 |
01P-0075 |
|
The Center for Reproductive Law & Policy / Switch Status of
Emergency Contraceptives from RX to OTC |
Interim Response 09/06/2001 |
| 02/22/2001 |
01P-0119 |
|
Dade Behring Inc. / Reclassification of Cyclosporine Diagnostic
Test Devices from Class III |
Pending |
| 02/23/2001 |
01P-0081 |
|
Lachman Consultant Services, Inc. / Midodrine Hydrochloride suitable
for consideration for ANDA |
Approved 05/08/2001 |
| 02/23/2001 |
01P-0083 |
|
United Animal Nations / Disclosure Source of Premarin |
Denied 05/10/2001 |
| 02/26/2001 |
01P-0085 |
|
Ferdale Laboratories Inc. / ANDA Suitable for topical cream containing
2% Hydrocortisone |
Approved 08/01/2001 |
| 02/26/2001 |
01P-0087 |
|
Life Techologies, Inc. / Request Classification for Dulbecco's
Modified Eagle Tissue |
NFR 66FR27023 05/16/2001 |
| 02/27/2001 |
01V-0102 |
|
Nth Degree Creative/Laser light show projector |
Approved 12/12/2006 |
| March |
|
|
|
|
| 03/01/2001 |
01P-0104 |
|
The Photronics Group / Exemption/Variance for Light-Emitting Products
|
Pending |
| 03/02/2001 |
01P-0108 |
|
Lachman Consultant Services, Inc. / Potassium Chloride Tablet
Suitable for Submission as an ANDA |
Pending |
| 03/02/2001 |
01P-0109 |
|
The Weinberg Group, Inc. / Declare doxycycline monohydrate capsules
suitable for ANDA |
Approved 08/02/2001 |
| 03/02/2001 |
01V-0110 |
|
OmniSistem Light and Effects / Laser Light Approved Show |
Approved 04/11/2005 |
| 03/06/2001 |
01P-0117 |
|
Mutual Pharmaceutical Company, Inc. / Rescind Approval of Solid
Oral Dosage form of Metaxalone |
Approved 01/30/2002 |
| 03/06/2001 |
01P-0120 |
|
Public Citizen Health Research Group / Ban Unsafe IV Catheters
and other Devices |
Denied 09/06/2001 |
| 03/08/2001 |
01P-0122 |
|
Pharmacia Consumer Healthcare Inc. / To Remove False and Deceptive
Labeling for Transderm Scop |
Approved 05/10/2002 |
| 03/12/2001 |
01P-0123 |
|
Idaho Cardiology Associates, PA / Electronic Lead Wires &
Patient Cables |
Pending |
| 03/12/2001 |
01P-0124 |
|
First Priority, Inc. / ANADA for Phenybutazone Tablets |
Approved 04/11/2001 |
| 03/13/2001 |
01P-0125 |
|
Olsson, Frank and Weeda, PC / ANDA Suitability Petition for Amiodarone
Hydrochloride Tablets |
Approved 08/02/2001 |
| 03/14/2001 |
01P-0130 |
|
Pharmaceutical Associates, Inc. / Hydrocodone Bitartrate and Acetaminophen
Products |
Approved 08/20/2001 |
| 03/15/2001 |
01P-0161 |
|
Veigh Hogan Jr. / Magnification Devices |
Pending |
| 03/16/2001 |
01P-0133 |
|
The Weinberg Group, Inc. / Dermatop Ointment Voluntarily Withdrawn
|
Withdrawn 06/18/2001 |
| 03/20/2001 |
01P-0136 |
|
Abbott Laboratories / ANDA filed for Midazolam Inejction (Preservative
Free) |
Pending |
| 03/20/2001 |
01P-0145 |
|
A R Hoenninger / Change the classification of Colonic Irrigation
Systems |
Approved 04/08/2004 |
| 03/21/2001 |
01P-0139 |
|
Vetoquinol N.-A., Inc. (Canada) / ANADA Suitability petition for
prednisolone oral paste |
Approved 12/19/2001 |
| 03/21/2001 |
01P-0140 |
|
Vetoquinol N.-A., Inc. (Canada) / ANADA Suitability for Cefadroxil
Oral Paste |
Approved 12/19/2001 |
| 03/21/2001 |
01P-0141 |
|
Vetoquinol N.-A., Inc. (Canada) / ANADA Suitability for Amoxicillin
Oral Paste |
Approved 12/19/2001 |
| 03/22/2001 |
01P-0144 |
|
PAI, Pharmaceutical Associates, Inc. / ANDA for Hydrocodone Bitartrate
& Acetaminophen Elixir Products |
Approved 08/20/2001 |
| 03/22/2001 |
01P-0148 |
|
Association of Disposable Devices (ADDM) / Misbranding or reprocessed
single use medical devices |
Denied 09/17/2001 |
| 03/30/2001 |
01V-0158 |
|
A.J.P. Laser / Precussion / Laser Light Show |
Approved 07/20/2004 |
| 03/27/2001 |
01P-0152 |
|
Apotex Corp. / Determine that Neurontin capsules was not withdrawn
for safety reasons |
Withdrawn 05/16/2006 |
| April |
Top |
|
|
|
| 04/02/2001 |
75N-0183H |
|
CTFA & The Soap and Detergent Assn. / Health-Care Antiseptic
Drug Products for OTC Human Use |
Pending |
| 04/03/2001 |
80N-0146 |
|
Oakhurst Co. / Nailbiting & Thumbsucking Deterrent Drug
Product for OTC Use |
Interim 10/02/2001 |
| 04/04/2001 |
01P-0235 |
|
Microgenics, Inc. / Reclassification of CyclosporineImmunoassay |
Pending |
| 04/06/2001 |
01V-0168 |
|
Starlight Laser / Laser Light Show |
Pending |
| 04/09/2001 |
01P-0169 |
|
Lotronex Action Group / Access & Safe Distribution of Alosetron |
Approved 02/12/2004 |
| 04/16/2001 |
01P-0186 |
|
Arnall Golden Gregory LLP / Determination that ANDA for Propoxyphene
Napsylate and Napsy |
Approved 08/20/2001 |
| 04/17/2001 |
01P-0187 |
|
Washington Legal Foundation / Exempt Internet Information from
FDA Labeling Requirements |
Denied 11/01/2001 |
| 04/21/2001 |
01P-0190 |
|
Judy Zapka & Center for Food Safety / Fountain Diet Coca-Cola
and Bottled Diet Coca-Cola |
Interim Response: 10/23/2001 |
| 04/22/2001 |
01P-0171 |
|
The Institute for Human Rights / Misbranding of regulated drugs
by third Parties |
Denied 05/28/2003 |
| 04/25/2001 |
01P-0130 |
|
Pharmaceutical Associates, Inc. / Hydrocodone Bitartrate and
Acetaminophen Products |
Denied 07/09/2002 |
| 04/26/2001 |
01V-0198 |
|
Box Electronics / Laser Light Show |
Approved 10/31/2003 |
| 04/30/2001 |
01P-0207 |
|
Lil' Drug Store Products, Inc. / Amend the final regulation on
OTC drug labeling content & fo |
Interim Response 1/18/2002 |
| May |
Top |
|
|
|
| 05/01/2001 |
01P-0209 |
|
Duramed Pharmaceuticals Inc / Prescription Drug Products list
amendment & approve new dosage |
Approved 07/03/2002 |
| 05/03/2001 |
01P-0214 |
|
PAI, Pharmaceutical Associates, Inc. / Declare ANDA may be
submitted for Hydrocodone bitartrate & A |
Approved 08/20/2001 |
| 05/09/2001 |
01P-0228 |
|
Bennett,Turner & Coleman,LLP / Clarify the"intended
use of" regulated/labeling products |
Interim Response: 11/05/2001 |
| 05/11/2001 |
01P-0230 |
|
Center for Food Safety / Domestic Marketing & Importation
of Transgenic Fish |
|
| 05/18/2001 |
01P-0244 |
|
Jeanie Ward / Investigate the Use of Polyethylene Glycol in
Children |
Interim Response: 02/20/2002 |
| 05/18/2001 |
01P-0245 |
|
Sidmak Laboratories, Inc. / Determination that Disulfiram was
withdrawn for reasons other than safety |
Closed 09/25/2001 |
| 05/24/2001 |
01P-0241 |
|
Cipher Pharmaceuticals Limited / ANDA Suitability for Paroxetine
"Caplet" |
Withdrawn 02/12/2004 |
| 05/24/2001 |
01P-0243 |
|
Cipher Pharmaceuticals Limited / ANDA Suitability for Fluoxetine
"Caplet" |
Withdrawn 07/31/2001 |
| 05/24/2001 |
01P-0239 |
|
Cipher Pharmaceuticals Limited / ANDA Suitability for Amlodipine
"Caplet" |
Withdrawn 02/12/2004 |
| 05/24/2001 |
01/P-0240 |
|
Cipher Pharmaceuticals Limited / ANDA Suitability for Ramipril
"Caplet" |
Withdrawn 07/31/2001 |
| 05/24/2001 |
01P-0242 |
|
Cipher Pharmaceutcials Limited / ANDA Suitability for Simvastin
"Caplet" |
Withdrawn 07/31/2001 |
| 05/29/2001 |
01P-0248 |
|
Federal Trade Commission / Clarify Issues Relating to Patent
Listings in " Orange Book" |
Interim Response: 12/21/2001 |
| 05/29/2001 |
01P-0250 |
|
Washington Legal Foundation / Dissemination of Non-Misleading
Information/Off-Label Uses |
Denied: 01/28/2002 |
| 05/29/2001 |
01P-0251 |
|
Mallinckrodt, Inc. / ANDA Suitability for Hydrocodone Bitartrate
& Acetaminophen |
Withdrawn 8/23/2001 |
| 05/29/2001 |
01P-0252 |
|
Mallinckrodt / ANDA Suitability for Dextroamphetamine Sulfate
Tablets 15 mg |
Interim Response 1/18/2002 |
| 05/29/2001 |
01P-0253 |
|
McDermott, Will & Emery / Include Chewing Gum as a Delivery
System for the Release of |
Closed 11/09/2001 |
| June |
Top |
|
|
|
| 06/04/2001 |
75N-183H |
|
CTFA & SDA / Health-Care Antiseptic Drug Products for OTC
Human Use |
Pending |
| 06/04/2001 |
01P-0258 |
|
Pharmacia & Upjohn / Request to revoke Approval of Suitability
Petitions 01P-0045 |
Pending |
| 06/05/2001 |
01P-0259 |
|
Public Citizen / Refuse to approve tegaserod (Zelmac) |
Approved 11/06/2001 |
| 06/12/2001 |
01P-0268 |
|
GlaxoSmithKline / Reformat label for prescription drug for
asthma medication |
Approved 01/11/2002 |
| 06/15/2001 |
01P-0272 |
|
Bio-Rad Laboratories / Permit mfrs. to remove intended use
statement from box label |
Pending |
| 06/26/2001 |
01P-0283 |
|
The Weinberg Group Inc. / ANDA for Pentoxifylline Extended-release
Tablets, 500 mg. |
Denied 07/03/2002 |
| 06/29/2001 |
01P-0288 |
|
Ferndale Laboratories Inc. / ANDA Suitability Petition for Fluorouracil
Topical Solution |
Approved 01/08/2002 |
| July |
Top |
|
|
|
| 07/02/2001 |
01P-0290 |
|
Hodgson Mill / Definition for the term "stone ground"
for wheat flour |
Pending |
| 07/02/2001 |
01P-0291 |
|
Ferndale Laboratories, Inc. / ANDA suitability for topical
cream containing 5% lidocaine |
Denied 07/03/2002 |
| 07/03/2001 |
01P-0304 |
|
Given Imaging Ltd / de nova Classification Given Diagnostic
Imaging System |
Pending |
| 07/09/2001 |
01M-0210 |
|
The TMJ Association / P000035;TMJ Fossa-Eminence Prosthesis
|
|
| 07/10/2001 |
01P-0298 |
|
Bio-Rad Laboratories / Permit Use of Symbols on In-Vitro Diagnostic
Labeling
|
Approved 11/18/2003 |
| 07/12/2001 |
92N-0297 |
|
Pharmaceutical Distributors Association / Prescription Drug
Marketing Act of 1987, Drug Amendments of 1992 |
Withdrawn 04/08/2002 |
| 07/12/2001 |
88N-0258 |
|
Pharmaceutical Distributors Association / Prescription Drug
Marketing Act of 1987, Guideline |
Withdrawn 04/08/2002 |
| 07/13/2001 |
01P-0302 |
|
TestoCreme, LLC / Anda Suitability Petition for TestoCreme
5% (Testosterone) |
Denied 04/12/2002 |
| 07/13/2001 |
01P-0303 |
|
Mary Masters / Petition of Declaration, Calcitek Inc. |
Pending |
| 07/24/2001 |
01P-0315 |
|
Aspire Pharmaceuticals Inc / Withdrawal of product from sale
in the US |
Interim Response 01/10/2002 |
| 07/26/2001 |
01P-0320 |
|
Center for Science in the Public Interest (CSPI) / Establish
Format Standards for Ingredient Labels on Food Products |
Interim Response 02/08/2002 |
| 07/30/2001 |
01P-0323 |
|
Pfizer Inc. & Pharmacia Corp. / Not rely on non-public
filings to approve an innovator NDA |
Denied 10/14/2003 |
| 07/30/2001 |
77N-0094 |
|
Bristol-Myers Squibb now Novartis Consumer Health / OTC Internal
Analgesic, Antipyretic & Antirheumatic Products |
Interim Response 02/05/2002 |
| 07/31/2001 |
01P-0334 |
|
Washington Legal Foundation / Revoke Invalid FDA Regulations
|
PAV/PDN in part 01/08/2002 |
| 07/31/2001 |
01V-0328 |
|
Stim-U-Lights/Laser Light Show |
Approved 05/06/2005 |
| August |
Top |
|
|
|
| 08/01/2001 |
01P-0333 |
|
ASTA Medica, Inc. / Non-lyophilized Cytoxan |
Closed 03/01/2004 |
| 08/01/2001 |
01P-0344 |
|
CAVITAT Medical Technologies, Inc. / de nova Classification
of Ultrasound Bone Densitometer |
Pending |
| 08/06/2001 |
75N-183H |
|
Soap & Detergent Assn. & CTFA / Health-Care Antiseptic
Drug Products for OTC Human Use |
Approved 07/25/2003 |
| 08/07/2001 |
01P-0340 |
|
Assn of Disposable Device Manufacturers / Regulate Reprocessed
Single Use Medical Devices as Reusable |
Denied 12/29/2004 |
| 08/07/2001 |
01P-0343 |
|
OSMA / Metal/Metal Semi-Constrained Hip Joint Prosthesis |
|
| 08/08/2001 |
01P-0346 |
|
SterilMed, Inc. / Modify 8/14/01 deadline re: submission &
approval of PMA |
Approved & Denied in part 8/14/2001 |
| 08/10/2001 |
01P-0349 |
|
Smart Drug Systems, Inc. / Sterile Injectable Compressed Rod
|
Withdrawn 09/07/2001 |
| 08/13/2001 |
01P-0350 |
|
Bennett & Company / Determine whether Sotradecol has been
withdrawn from sale for safety reasons |
Interim Response 02/05/2002 |
| 08/13/2001 |
01P-0351 |
|
Bennett & Company / ANDA for sodium tetradecyl sulfate
injection strengths 0.5% & 0.2 |
Denied 04/12/2002 |
| 08/13/2001 |
01P-0345 |
|
Heather Brodie Perry / Listing the color additive yellow #5
for use in food/Drug |
Interim Response 02/06/2002 |
| 08/14/2001 |
01P-0353 |
|
Aspire Pharmaceuticals Inc. / ANDA for a generic albuterol inhalation
aerosol |
Approved 05/23/2002 |
| 08/15/2001 |
01P-0354 |
|
Public Citizen / Immediately ban the sale of human cadaveric
dura mater |
Denied 02/11/2002 |
| 08/15/2001 |
01P-0355 |
|
Ferndale Labs., Inc. / ANDA suitability for hydrocortisone
acetate lotion, 2.5% |
Pending |
| 08/15/2001 |
01P-0356 |
|
Lachman Consultant Services Inc / Amend approved drug products
with "Orange Book" 21st list |
Approved 05/31/2002 |
| 08/16/2001 |
00P-1486 |
|
Equi Aid Products, Inc. / ANADA Suitability Petition for a
Generic Oral Ivermectin |
Pending |
| 08/17/2001 |
01P-0358 |
|
The Weinberg Group, Inc. / ANDA for drug Carbidopa-Levodopa
dispersible tablets, 10mg |
Pending |
| 08/24/2001 |
01P-0374 |
|
Lachman Consultant Service, Inc / ANDA for Hydrocodone Bitartrate
and Acetaminophen Elixir,7.5 |
Withdrawn 01/07/2002 |
| 08/27/2001 |
01P-0372 |
|
Public Citizen / Require Box Warning on HMG-CoA Reductase
Inhibitors, Statins |
Interim Response 02/15/2002 |
| 08/30/2001 |
01A-0375 |
|
Pennsylvania Department of Health / Preempt PA Regulations
on Human Specimens for Testing |
Interim Response 04/04/2002 |
| 08/30/2001 |
01P-0377 |
|
Lachman Consultant Services, Inc. / Methadone Hydrochloride
Tablets, USP 15mg, 20 mg, 30 mg & 40 |
Pending |
| 08/30/2001 |
01V-0378 |
|
Dymax Laser Technologies/Laser Light Show |
Approved 03/02/2006 |
| 08/30/2001 |
01P-0379 |
|
AAI International / ANDA Suitability for a Change in Dosage
Form for Imuren |
Approved 12/17/2001 |
| September |
Top |
|
|
|
| 09/04/2001 |
01P-0382 |
|
ECO LLC / ANADA suitability which differs in dosage form from
innovator |
Approved 11/06/2001 |
| 09/04/2001 |
01P-0383 |
|
AAI International an aai Pharma Co. / Determine whether Imuran
tablets were withdrawn for safety reasons |
N1 67FR7701 02/20/2002 |
| 09/04/2001 |
01P-0385 |
|
Cross Vetpharm Group Ltd. / ANADA Suitability for Oxytetracycline
300 mg/mL injection |
Denied 02/14/2002 |
| 09/05/2001 |
01P-0389 |
|
Kyper & Associates LLC / Revoke CPG 7383.003 for Class
III 510(k) Devices Pre-amend |
Pending |
| 09/06/2001 |
01V-0393 |
|
Ace Mitchell Bowler's Mart / Laser Light Show |
Approved 10/16/2003 |
| 09/06/2001 |
01P-0394 |
|
ECO LLC / ANADA generic equivalent of innovator product Heartgard
30 |
Approved 11/06/2001 |
| 09/06/2001 |
75N-183H |
|
Procter & Gamble Company / Health-Care Antiseptic Drug
Products for OTC Human Use |
Closed 04/19/2002 |
| 09/10/2001 |
01P-0396 |
|
Public Citizen / Request that FDA ban the production and sale
of all ephedra |
Pending |
| 09/17/2001 |
75N-183H |
|
Ciba Specialty Chemicals Corporation / Health-Care Antiseptic
Drug Products for OTC Human Use |
Pending |
| 09/17/2001 |
01P-0406 |
|
International Bottle Water Assn. / To require Telephone Contact
Information on label of bottled |
Pending |
| 09/19/2001 |
01P-0426 |
|
Lachman Consultant Services, Inc. / Determine Status of Oxycontin
Extended-Release Tabs. 160 mg |
Interim Response 03/21/2002 |
| 09/20/2001 |
01P-0430 |
|
GensiaSicor Pharmaceuticals / Propofol Injectable Emulsion
1%,10mg/mL Formulation 0.025% |
Pending |
| 09/20/2001 |
01P-0427 |
|
Karen A. Sisson / ANADA Suitability for Eqvalan Paste 1.87%
to Liquid |
Pending |
| 09/20/2001 |
01P-0428 |
|
Professional Detailing, Inc. / Generic Cefuroxime Axetil Products
|
Denied 02/15/2002 |
| 09/20/2001 |
01P-0425 |
|
First Priority, Inc. / ANADA Suitability for Heartgard 30
Chewables |
Approved 11/15/2001 |
| 09/20/2001 |
01P-0446 |
|
Robert Katock / Reinstate Whitfield's Ointment |
Pending |
| 09/26/2001 |
01P-0428 |
|
Professional Detailing, Inc. / Generic Cefuroxime Axetil Products
|
Denied 02/15/2002 |
| 09/27/2001 |
01P-0440 |
|
Ben Venue Laboratories, Inc. / ANDA Suitability Petition for
Ganciclovir Sodium Injection |
Pending |
| 09/28/2001 |
01P-0443 |
|
Gail Elbek / Estrogen & progestin drug info available
to the public is "M |
Denied 12/04/2001 |
| 09/28/2001 |
01P-0447 |
|
John W. Herr / Withdrawn for Safety or Effectivess of Ardeparin
Sodium |
N. 67FR36297 05/23/2002 |
| 09/28/2001 |
01P-0442 |
|
Lachman Consultant Services, Inc. / Hydrocodone Bitartrate/Ibuprofen
Tablets 10mg/200mg |
Approved 12/20/2001 |
| 09/28/2001 |
01P-0441 |
|
Lachman Consultant Services, Inc. / Hydrocodone Bitartrate/Acetaminophen
tablets,10mg/300mg |
Approved 12/20/2001 |
| 09/28/2001 |
01P-0445 |
|
Taro Pharmaceuticals U.S.A. , Inc. / ANDA suitability for
Amiodarone hydrochloride tablets 100mg |
Withdrawn |
| October |
Top |
|
|
|
| 10/02/2001 |
01P-0449 |
|
Roxane Laboratories, Inc. / ANDA Suitability for Digoxin Elixir,
0.05 mg/mL |
Withdrawn 12/20/2001 |
| 10/05/2001 |
99P-2077 |
|
Health Care Without Harm / Reg/Guide to Label Medical Devices
containing Phthalate Plastics |
Denied 04/05/2002 |
| 10/10/2001 |
00P-1439 |
|
Iceberg Industries Corporation / Iceberg Water Deviating From
Identity Standard |
Interim Response 03/22/2002 |
| 10/10/2001 |
01P-0470 |
|
Boehringer Ingelheim Pharm, Inc. / Establish Appropriate Approval
Standards for Generic Clonidi |
Interim Response 04/04/2002 |
| 10/10/2001 |
00P-1322 |
|
Center for Science in the Public Interest (CSPI) / Food Labeling
and Allergen Contamination Control |
Pending |
| 10/11/2001 |
97P-0441 |
|
Pharmanex, LLC / Regulatory Status of Cholestin red yeast
rice |
Withdrawn 07/08/2003 |
| 10/11/2001 |
01P-0470 |
|
Boehringer Ingelheim Pharm, Inc / Establish Appropriate Approval
Standards for Generic Clonidi |
Interim Response 04/04/2002 |
| 10/15/2001 |
01P-0471 |
|
Russell E. Dingle & Thomas L. Rempfer / Issue the NFR
Placement of Anthrax Vaccine as Category II |
Interim Response 04/11/2002 |
| 10/17/2001 |
01P-0481 |
|
Elan Pharmaceuticals, Inc. / In Vivo Bioequivalance Study
for Generic Skelaxin Tablets |
Approved 03/21/2002 |
| 10/19/2001 |
01P-0505 |
|
Andrea James / Administrative Reconsideration for K892514
Epilator 629 |
Pending |
| 10/23/2001 |
01P-0492 |
|
McDermott, Will & Emery / ANDA Suitability Petition for
Ondansetron HCL Tablets, 16 mg |
Approved 04/12/2002 |
| 10/25/2001 |
01P-0495 |
|
Apotex Corp. / Determine Ultram's safety or effectiveness
reasons |
Approved & Denied in Part 06/11/2002 |
| 10/31/2001 |
00N-0018 |
|
Orthopedic Surgical Manufacturers Assn. / Reclassification
of the knee joint Patellofemorotibal Metal |
Pending |
| November |
Top |
|
|
|
| 11/05/2001 |
01P-0504 |
|
ANDAFAB ONE LP / ANDA Suitability for Hydrocodone Bitartrate
& Acetaminophen |
Withdrawn 01/02/2002 |
| 11/07/2001 |
76N-0482 |
|
Dr. Leslie S. Aufseeser / Establishment of Monograph for OTC
Topical Antibiotic Products |
Answered 07/22/2003 |
| 11/09/2001 |
01P-0511 |
|
Ferndale Laboratories, Inc. / ANDA suitability for hydrocortisone
acetate lotion 2.5% |
Interim Response 02/03/2004 |
| 11/09/2001 |
01P-0515 |
|
Lachman Consultant Services, Inc. / ANDA for Doxycycline Monohydrate
Tablets, 75mg |
Approved 04/12/2002 |
| 11/09/2001 |
01P-0516 |
|
Lachman Consultant Services, Inc. / ANDA for Doxycycline Monohydrate
Tablets, 150mg |
Approved 04/12/2002 |
| 11/09/2001 |
01P-0518 |
|
Consumer Electronic Assn / Improve Rules for TV Sets |
Denied 05/17/2002 |
| 11/13/2001 |
01P-0517 |
|
Heike Karsch / Reclassify Methylenedioxymethamphetamine as
Schedule II |
Closed 12/03/2001 |
| 11/15/2001 |
01P-0521 |
|
Atley Pharmaceuticals, Inc. / ANDA for a tableted containing
hydrocodone bitartrate & acetaminophen |
Denied 07/03/2002 |
| 11/20/2001 |
01P-0524 |
|
Lachman Consultant Services, Inc. / Hydrocodone Bitartrate
& Acetaminophen Oral Solution 10 mg |
Pending |
| 11/21/2001 |
01P-0526 |
|
Atley Pharmaceuticals, Inc. / ANDA Suitability for 200 mg
Carisoprodol Oral Tablets |
Denied 07/03/2002 |
| 11/27/2001 |
01P-0529 |
|
Mylan Pharmaceuticals, Inc. / Request that '365 Patent Not
be Re-listed in Orange Book |
Closed 11/05/2004 |
| 11/28/2001 |
75N-183H |
|
The Soap & Detergent & C.T.F.A / Health-Care Antiseptic
Drug Products for OTC Human Use |
Pending |
| 11/29/2001 |
01P-0533 |
|
PharmaForce, Inc. / Determine whether Rubrmin PC 1mg/mL &
10-ml has been voluntarily withdrawn |
Interim Response 05/29/2002 |
| 11/29/2001 |
01P-0542 |
|
Meridian Medical Technologies / ANDA suitability for Diazepam
Injection Auto-Injector |
Interim Response 05/29/2002 |
| December |
Top |
|
|
|
| 12/07/01 |
01P-0350 |
|
Omega Laboratories, Ltd. / Determine whether Sotradecol has
been withdrawn from sale for safety or efficacy reasons |
Pending |
| 12/07/2001 |
01P-0546 |
|
Pharmacia Corporation / ANDA for Covera-HS |
Denied and Approved in part 11/21/2003 |
| 12/10/2001 |
01P-0547 |
|
Lachman Consultant Services, Inc. / Methenex(Methadone Hydrochloride
40mg Naloxone Hydrochloride |
Pending |
| 12/11/2001 |
01P-0549 |
|
Lachman Consultant Services, Inc. / Determination of Nitroglycerin
Aerosol (sublingual) |
Withdrawn 09/07/2006 |
| 12/11/2001 |
01P-0560 |
|
Hogan & Hartson, LLP / Refrain Approval of Any Buprenorphine
Product |
Interim Response 06/07/2002 |
| 12/18/2001 |
01P-0570 |
|
National Center for Tobacco-Free Kids / Petition for Regulation
of R.J. Reynolds Eclipse Products |
|
| 12/18/2001 |
01P-0571 |
|
National Center for Tobacco-Free Kids / Petition for Regulation
of Vector's OMNI Cigarettes and Star |
|
| 12/18/2001 |
01P-0572 |
|
National Center for Tobacco-Free Kids / Petition for Regulation
of Ariva Tobacco Lozenges |
Denied 08/29/2003 |
| 12/18/2001 |
01P-0573 |
|
National Center for Tobacco-Free Kids / Petition for Regulation
of S & F Nicotine Water |
|
| 12/19/2001 |
01P-0574 |
|
Ben Venue Laboratories, Inc. / Referencing discontinued labeling
for Octreotide acetate injection |
Approved 03/25/2005 |
| 12/27/2001 |
01P-0585 |
|
Arnall Golden Gregory, LLP / Requirement of ANDA for Mixed
Salts of Single Entity Amphet |
Interim Response 02/13/2002 |
| 12/27/2001 |
01P-0586 |
|
Bristol-Myers Squibb Company / New and/or Amended Regulations
for BPCA |
Denied 01/24/2002 |
| 12/28/2001 |
75N-183H |
|
Bayer Corp. / Health-Care Antiseptic Drug Products for OTC Human
Use |
Pending |
