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U.S. Department of Health and Human Services

Regulatory Information

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2001 Chronological List of Petitions and Advisory Opinions

 To view actual documents, make a note of the docket number, go to regulations.gov and enter the docket number in the search box. You will then get everything associated with that docket number.

Interim Response is not a final decision on the petition.

January | February | March | April | May | June | July | August | September | October | November | December

Date Filed Docket # Name of Petitioner/Subject Matter Disposition
January      
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
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February      
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
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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
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April      
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
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May      
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
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June      
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
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July      
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
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August      
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
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September      
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 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
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October      
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
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November      
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
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December      
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  
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
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