New!  As of May 1, 2004, New and Generic Drug Approvals 1998-2004, will not be updated. 
Please use Drugs@FDA for all drug approval information, which includes the content of this page.

 

Product Name Company Application # Approval
Date

Letter
Posted

Label
Posted 		Review
Posted
Pacerone (Amiodarone Hydrochloride) Tablets, 200mg Upsher-Smith Laboratories, Inc. ANDA 75-135/S3 9/24/99 10/29/02    
Pacerone (Amiodarone Hydrochloride) Tablets, 200mg Upsher-Smith Laboratories, Inc. ANDA 75-135/S1-7 4/30/98     10/29/02
Pacerone (Amiodarone Hydrochloride) Tablets, 200mg Upsher-Smith Laboratories, Inc. ANDA 75-135 4/30/98     5/28/99
Paclitaxel Injection, 6 mg/mL, Rx NaPro Biotherapeutics, Inc. ANDA 76-233 8/1/02      
Paclitaxel Injection, 6 mg/mL, Rx Abbott Laboratories ANDA 76-131 5/8/02      
Paclitaxel Injection, 6 mg/mL, Rx Zenith Goldline Pharmaceuticals, Inc. ANDA 75-297 3/27/01 3/30/01   12/20/01
Paclitaxel Injection, 6 mg/mL, Rx,  tentatively Approved Zenith Goldline Pharmaceuticals, Inc. ANDA 75-297 10/10/00 10/30/00    
Paclitaxel Injection, 30 mg/5mL (6 mg/mL), Rx Mylan Pharmaceuticals, Inc. ANDA 75-278 7/23/01      
Paclitaxel Injection, 30 mg/5mL (6 mg/mL), Rx,  tentatively Approved Mylan Pharmaceuticals, Inc. ANDA 75-278 9/19/00 10/30/00    
Paclitaxel Injection, 6 mg/mL, Rx,  tentatively Approved Zenith Goldline Pharmaceuticals, Inc. ANDA 75-227 10/10/00      
Paclitaxel Injection, 6 mg/mL, Rx Bedford Laboratories ANDA 75-190 7/27/01 4/9/03    
Paclitaxel Injection, 6 mg/mL, Rx Baker Norton Pharmaceuticals, Inc. ANDA 75-184 9/15/00 10/31/00   8/6/03
Paclitaxel Injection, 6 mg/mL, Rx,  tentatively Approved Baker Norton Pharmaceuticals, Inc. ANDA 75-184 8/28/00 9/12/00    
Pamelor Capsules & Oral Solution,  Tyco Healthcare NDA 18-012/S24 7/31/01   7/31/01  
Pamidronate Disodium Injection, 3 & 9 mg/mL, Rx American Pharmaceutical Partners, Inc. ANDA 76-207 5/17/02      
Pamidronate Disodium Injection, 3 & 9 mg/mL, Rx Gensia Sicor Pharmaceuticals, Inc. ANDA 76-153 3/27/02 4/10/03    
Pamidronate Disodium Injection, 3 & 9 mg/mL, Rx Tentatively Approved Gensia Sicor Pharmaceuticals, Inc. ANDA 76-153 2/28/02 4/11/03    
Pamidronate Disodium Injection, Rx Bedford Laboratories NDA 21-113 3/4/02 3/12/02 5/30/02 5/30/02
Pamidronate Disodium Injection, Rx  Faulding Pharmaceutical Co. ANDA 75-841 6/27/02      
Pamidronate Disodium Injection, 30 mg/vial, & 90 mg/vial, Rx  American Pharmaceutical Partners Inc. ANDA 75-773 5/6/02      
Pamidronate Disodium Injection, 30 mg/vial, & 90 mg/vial, Rx Tentatively Approved American Pharmaceutical Partners Inc. ANDA 75-773 8/24/01 4/15/03    
Pamidronate Disodium Injection, 30 mg/vial, & 90 mg/vial, Rx Aesgen, Inc. ANDA 75-594 5/6/02      
Pamidronate Disodium Injection, 30 mg/vial, & 90 mg/vial, Rx Tentatively Approved Aesgen, Inc. ANDA 75-594 11/28/01 4/14/03    
Pamidronate Disodium Injection, 30 mg/vial, & 90 mg/vial, Rx Bedford Laboratories ANDA 75-290 4/30/01 6/5/01   12/26/01
Pamine (methscopolamine bromide) Tablets, Rx Bradley Pharmaceuticals NDA 8-848/S-024 3/25/03 4/1/03    
Panretin (alitretinoin) Gel, 0.1%, Rx Ligand Pharmaceuticals NDA  20-886 2/2/99 2/5/99 2/5/99 6/16/99
  Panretin Indication: Treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma.
Parafon (chlorzoxazone) Forte DSC, 500 mg McNeil Consumer Products Company NDA 11-529/S-048 6/28/02 7/2/02    
Paragard Intrauterine Contraceptive Ortho-McNeil NDA 18-680s55 8/24/01   4/30/03  
Paremyd (hydroxyamphetamine hydrobromide/tropicamide opthamlmic solution ) Akorn NDA  19-261/S-008 12/04/01   4/15/03  
Paraplatin (Carboplatin Aqueous Solution) Injection,  Bristol-Myers Squibb Co. NDA 20-452/S1 1/9/04 1/14/04 1/15/04  
Paraplatin (Carboplatin Aqueous) Solution Injection,  Bristol-Myers Squibb Co. NDA 20-452 7/14/03 7/28/03    
Paraplatin (Carboplatin) Injection Bristol-Myers Squibb NDA 19880/S011 2/14/02 3/8/02    
Paraplatin (Carboplatin) Injection Bristol-Myers Squibb NDA 19880/S009 1/6/98     7/6/00
Parnate (tranylcypromine sulfate) Tablets, 10 mg SmithKline Beecham NDA 12-342/S037, 039, 040, 044, 046, 048, & 051 3/15/01 5/1/01    
Paroxetine Hydrochloride Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Rx Alphapharm ANDA 75-716 3/8/04
Paroxetine Hydrochloride Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Rx Tentatively Approved Alphapharm ANDA 75-716 9/29/03
Paroxetine Hydrochloride Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Rx Sandoz, Inc. ANDA 75-566 3/8/04
Paroxetine Hydrochloride Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Rx Tentatively Approved Sandoz, Inc. ANDA 75-566 2/18/04
Paroxetine Hydrochloride Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Rx Apotex/U.S Agent for Torpharm ANDA 75-356 7/30/03 7/31/03    
Paroxetine Hydrochloride Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Rx Tentatively Approved Torpharm ANDA 75-356 5/24/01 6/5/01    
Paroxetine Mesylate Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Rx Synthon Pharmaceuticals NDA 21-299/S1 8/21/03 8/28/03  
Paroxetine Mesylate Tablets, 10 mg, 20 mg, 30 mg, 40 mg, Rx Synthon Pharmaceuticals NDA 21-299 7/3/03 10/17/03 8/6/03  
Patanol (olopatadine hydrochloride ophthalmic solution), 0.1%, Rx Alcon Laboratories, Inc. NDA 20-688/S-016 4/17/03      
Patanol (olopatadine ophthalmic solution), 0.1%, Rx Alcon Laboratories Inc. NDA 20-688/S12 3/20/00 3/21/00    
  Patanol Indications:  Treatment of signs and symptoms of allergic conjunctivitis.
Paxil (paroxetine HCl) Imm ediate-Release & Controlled-Release Tablets, Rx GlaxoSmithKline NDA 20-031/S40 & 20-936/S16 4/8/04      
Paxil CR (paroxetine HCl) Controlled-Release Tablets, Rx GlaxoSmithKline NDA 20-936/S13 1/27/04 2/2/04 2/2/04  
Paxil CR (paroxetine HCl)  Tablets, Rx GlaxoSmithKline NDA 20-936/S-012 8/28/03 10/17/03  10/17/03  
Paxil CR (paroxetine HCl)  Tablets, Rx GlaxoSmithKline NDA 20-936/S-011 8/28/03 09/09/03 09/09/03  
Paxil CR (paroxetine HCl)  Tablets, Rx GlaxoSmithKline NDA 20-982 & 20-936/S-008 2/12/02 2/21/02 2/21/02 6/25/02
Paxil CR (paroxetine HCl)  Tablets, 12.5 and 25 mg, Rx SmithKline Beecham NDA 20-936 2/16/99 2/17/99 3/4/99 7/26/01
  Paxil Indication: Treatment of Depression
Paxil Capsules, 10 mg, 20 mg, 30, and 40 mg, Rx SmithKline Beecham NDA 20-885 10/9/98 10/13/98   12/14/98
  Paxil Indication: Depression/OCD/Panic Disorder
Paxil (paroxetine hydrochloride) Tablets, Rx GlaxoSmithKline NDA 20-031/S-035 10/2/02 10/2/02    
Paxil (paroxetine hydrochloride) Tablets, GlaxoSmithKline NDA 20-031/S-023 5/11/99   4/24/03  
Paxil (paroxetine) Tablets, Rx GlaxoSmithKline NDA 20-031/S-029 12/14/01 2/12/02 2/12/02  
Paxil (paroxetine hydrochloride) Tablets SmithKline Beecham NDA 20-031/S-023 5/17/99 5/18/99    
Paxil (paroxetine HCI) Tablets, Rx GlaxoSmithKline NDA 20-031/S-026 4/13/01 5/03/01 5/03/01  
Pediapred (prednisolone sodium phospahte, USP) Oral Solution, Rx Medeva Pharmaceuticals NDA 19-157/S-016 1/21/98     9/11/03
Pediapred (prednisolone sodium phospahte, USP) Oral Solution, Rx Medeva Pharmaceuticals NDA 19-157/S-011, S-012, S-013, S-015 12/18/98 12/18/98    
Pediazole (erythromycin ethylsuccinate and sulfisoxazol acetyl), Oral Suspension, Ross Products Division NDA 50-529/S-033 2/9/04 2/27/04
Peganone (ethotoin) 250 mg Tablets, Rx Ovation Pharmaceuticals, Inc. NDA 10-841/S-013/S-014 9/26/03 10/1/03    
Pemoline Tablets, 18.75 mg, 37.5 mg, and 75 mg, Rx only Mallinckrodt, Inc. ANDA 75-726 3/30/01 4/2/01    
Pemoline Chewable Tablets, 37.5 mg, Rx Amide Pharmaceutical, Inc. ANDA 75-678 7/26/00 11/7/00    
Pemoline Chewable Tablets, 37.5 mg, Rx Copley Pharamceutical, Inc. ANDA 75-555 2/18/00 2/24/00    
Pemoline Tablets, 18.75 mg, 37.5 mg & 75 mg., Rx Amide Pharmaceutical, Inc. ANDA 75-595 2/28/00 2/29/00    
Pemoline Tablets, 18.75 mg, 37.5 mg, 75 mg, Rx Vintage Pharmaceuticals Inc. ANDA 75-328 4/19/00 4/24/00    
Pemoline Tablets, 37.5 mg & 75 mg., Rx Watson Laboratories Inc. ANDA 75-287 9/18/00 10/30/00    
Pemoline Tablets, 37.5 mg & 75 mg. Invamed Inc. ANDA 75-286 6/30/99 7/2/99    
Pemoline Tablets, 37.5 mg, and 75 mg, Rx only Copley Pharmaceutical, Inc. ANDA 75-030 1/29/99 1/29/99    
  Pepcid AC Indications:1) For the relief of heartburn, acid indigestion, and sour stomach.   2) For the prevention of heartburn, acid indigestion, and sour stomach brough on by consuming food and beverages.
Penetrex (enoxacin) Tablets, 200 mg and 400 mg.  Aventis Pharmaceuticals NDA 19-616/S-004, S-005, S-006 8/21/02 8/26/02    
Penicillin G Potassium Injection, USP, 1,000,000; 5,000,000; & 20,000,000 Units, Rx Biochemie GmbH NDA 65-079 8/30/02      
Penicillin G Potassium Injection, USP, in Galaxy Container Baxter Healthcare Corporation NDA 50-638/S-007 8/23/02 8/30/02    
Penicillin G Sodium for Injection USP,Rx Biochemie GmbH ANDA 65-068 2/26/01 3/6/01    
Penlac Nail Lacquer (ciclopirox) Topical Solution, 8%. Dermik Labroatories NDA 21-022/S3 12/22/03 12/24/03 12/29/03  
Penlac Nail Lacquer (ciclopirox) Topical Solution, 8%. Aventis Pharmaceuticals,  Inc. NDA 21-022/S2 6/9/03 7/8/03 7/7/03  
Penlac Nail Lacquer (ciclopirox) Topical Solution, 8%. [Package Labeling] Aventis Pharmaceuticals,  Inc. NDA 21-022 12/17/99 12/27/99 12/27/99 8/20/02
  Penlac Indications:provides for the use of  PENLAC™ NAIL LACQUER (ciclopirox) Topical Solution, 8%, as a component of a comprehensive management program, for the topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum.
Pentasa (Mesalamine) Capsules Roberts Laboratories Inc. NDA 20-049/S006 9/10/99     6/19/01
Pentazocine & Naloxone Hydrochloride Tablets, 50 mg (base) & 0.5 mg (base), Rx Amide Pharmaceutical Inc. ANDA 75-735 7/11/01      
Pentazocine & Naloxone Hydrochloride,50 mg (base) & 0.5 mg (base), Rx Ranbaxy Laboratories Limited ANDA 75-523 3/17/00 3/21/00   6/7/01
Pentazocine Hydrochloride & Acetaminophen, 25 mg (base)/650, Rx Watson Laboratories, Inc. ANDA 74-699 3/24/00 3/31/00    
Pentazocine Hydrochloride & Acetaminophen Tablets, 25 mg (base)/650, Rx Amide Pharmaceuticals ANDA 76-202 8/2/02      
Pentoxifylline Extended-release Tablets, 400mg IMPAX Pharmaceuticals ANDA 75-093 8/10/99 8/24/99    
Pentoxifylline Extended-release Tablets, 400mg Keller and Heckman ANDA 75-028 7/20/98 7/20/98   9/25/02
Pentoxyfilline Extended-release Tablets, 400 mg, Rx Watson Laboratories ANDA 75-107 9/4/98 9/8/98    
Pentoxyfilline Extended-release Tablets, 400 mg. Apotex Corp. ANDA 75-191 6/9/99 6/11/99    
Pentoxyfilline Extended-release Tablets, 400 mg Teva Pharmaceuticals ANDA 75-199 9/3/99 9/14/99    
Pentoxyfilline Extended-release Tablets, 400 mg, Rx Sidmak Laboratories, Inc. ANDA 74-874 5/25/99 6/1/99    
Pentoxifylline Extended-release Tablets, 400 mg. Upsher-Smith Laboratories, Inc. ANDA 74-962 3/31/99 4/1/99   4/22/03
Pepcid AC Coated Tablets,10 mg, OTC Merck & Co., Inc NDA 19-462     4/30/03  
Pepcid AC Coated Tablets,10 mg, OTC Merck & Co., Inc NDA 19-462/S29 4/25/01   4/23/03  
Pepcid Complete Chewable Tablets, Oral Suspension, Orally Disintegrating Tablets Merck & Co., Inc NDA 19-510 11/4/86   4/30/03  
Pepcid AC Coated Tablets,10 mg, OTC Merch Research Laboratories NDA 20-902 8/5/99     5/16/00
Pepcid AC (Famotidine) Tablets,  Merck & Co., Inc. NDA 20-325/S15 9/23/03 9/30/03 9/30/03
Pepcid AC Film Coated Tablets,  Merck & Co., Inc. NDA 20-325/S-013 3/1/02 3/5/02    
Pepcid AC Film Coated Tablets,  Merck & Co., Inc. NDA 20-325/S-3 3/1/02 3/6/02    
Pepcid AC (famotidine) Chewable Tablets, OTC Merck & Co., Inc. NDA 20-801/S-007 1/31/02 3/6/02    
Pepcid AC Chewable Tablets, OTC Merck Reseach Laboratories NDA 20-801/S-004 4/10/01 4/9/03 5/9/03  
Pepcid AC (famotidine) Chewable Tablets,OTC Merck Reseach Laboratories NDA 20-801 9/24/98 9/25/98 9/25/98 3/16/99
  Pepcid AC Indications:1) For the relief of heartburn, acid indigestion, and sour stomach.   2) For the prevention of heartburn, acid indigestion, and sour stomach brough on by consuming food and beverages.
Pepcid Complete Tablets, Merck NDA 20-958/S7 11/06/03 11/13/03
Pepcid Complete Chewable Tablets, Oral Suspension, Orally Disintegrating Tablets Merck Research Laboratories NDA 20-958/S2 11/06/01   04/25/03  
Pepcid Complete Chewable Tablets, OTC Merck Research Laboratories NDA 20-958 10/16/00 10/20/00 10/30/00 9/25/03
  Pepcid Indication:for use in the relief of heartburn associated with acid indigestion and sour stomach.
Pepcid (famotidine) Coated (gelatin coated, capsule
shaped) Tablets		 Merck Research Laboratories NDA 20-752 8/5/99 8/6/99 8/6/99  
  Pepcid Indication:1. Treatment of Heartburn associated with acid indigestion and sour stomach        2. Prevention of meal-induced heartburn
Pepcid (famotidine) RPD Orally Disintegrating Tablets,20 and 40 mg Merck Research Laboratories NDA 20-752 5/28/98 6/1/98 6/1/98  
  Pepcid RPD Indication:This application provides for a new dosage form for prescription pepcid (famotidine) which is indicated for the treatment of ulcers, GERD, and hypersecretory disease (see labeling for details).
Pepcid (famotidine) Coated (gelatin coated, capsule
shaped) Tablets		 Merck Research Laboratories NDA 20-752 8/5/99      
  Pepcid Indication:1. Treatment of Heartburn associated with acid indigestion and sour stomach        2. Prevention of meal-induced heartburn
Pepcid (Famotidine) Tablets, Oral Suspension, Orally Disintegrating Tablets Merck Research Laboratories NDA 19-462/S31, 19-527/S25, & 20-752/S6 3/14/01      
Pepcid (Famotidine) Tablets, Injection, & Oral Suspension,  Merck and Co. Inc. NDA 19-462/S30, 19-527/S24, & 20-752/S5 6/6/02 6/14/02 6/7/02  
Pepcid (Famotidine) Tablets, Injection, & Oral Suspension,  Merck Research Laboratories NDA 19-462/S27, 19-527/S20, & 20-752/S2 3/18/99     7/5/00
Pepcid (Famotidine) Injection & Injection Premixed,  Merck Research Laboratories NDA 19-510/S029 & 20-249/S12 3/14/01 4/27/01 4/27/01  
Pepcid (Famotidine) Injection & Injection Premixed,  Merck and Co., Inc. NDA 19-510/S028 & 20-249/S011 6/6/02 6/14/02 6/7/02  
Pepcid (Famotidine) Injection & Injection Premixed,  Merck Research Laboratories NDA 19-510/S026 & 20-249/S09 3/18/99     8/17/99
  Pepcid Indications:  Short term treatment of active duodenal ulcer.
Percocet (Oxycodone Hydrochloride and Acetaminophen) Tablets USP, 7.5 mg/325 mg & 10 mg/325 mg, Rx Endo Pharmaceuticals, Inc. ANDA 40-434 11/23/01 4/10/03    
Percocet (Oxycodone and Acetaminophen) Tablets USP, 7.5 mg/500 mg & 10 mg/650, Rx Endo Pharmaceuticals ANDA 40-341 7/26/99 7/29/99   1/17/02
Percocet (Oxycodone andAcetaminophen) Tablets USP, 2.5mg/325mg & 5mg/325mg. Endo Pharmaceuticals Inc. ANDA 40-330 6/25/99 6/28/99   1/17/02
Pergolide Mesylate Tablets, 0.05, 0.25 & 1 mg (base), Rx Ivax Pharmaceuticals ANDA 76-094 9/4/03
Pergolide Mesylate Tablets, 0.05, 0.25 & 1 mg (base), Rx Tentatively Approved Ivax Pharmaceuticals ANDA 76-094 4/24/03      
Pergolide Mesylate Tablets, 0.05 mg (base), 0.25 mg (base), & 1 mg (base), Rx TEVA Pharmaceuticals USA ANDA 76-061 11/27/02      
Pergonal (menotropins) Injection,  Serono, Inc. NDA 17-646/S-049 7/30/02 8/6/02    
Periactin (Cyproheptadine HCI) Tablets, 4 mg Merck & Co. Inc. NDA 12-649/S46 9/24/99     5/21/01
PerioChip (Chlorhexidine gluconate), 2.5 mg Dexcel Pharma Technologies, LTD. NDA 20-774/S7 3/2/04 3/3/04 4/5/04  
PerioChip (Chlorhexidine gluconate), 2.5 mg Dexcel Pharma Technologies, LTD. NDA 20-774/S3 12/15/02 1/29/03 12/16/02  
PerioChip (Chlorhexidine gluconate), 2.5 mg Target Research Associates NDA 20-774 5/15/98 5/15/98 5/15/98  1/7/99
  PerioChip Indications: PerioChip is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. PerioChip may be used as a part of a periodontal maintenance program, which includes good oral hygiene and scaling and root planing.
Periostat Capsules,  20 mg., Rx CollaGenex Pharmaceuticals NDA 50-744 10/1/98 10/1/98 10/1/98 1/13/99
  PerioStat Indication: Provides for the use of Periostat (doxycycline hyclate, USP) Capsules, 20 mg as an adjunct to subgingival scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.
Periostat (doxycycline hyclate) Tablets,  20 mg., Rx CollaGenex Pharmaceuticals NDA 50-783/S2 3/31/04 4/7/04 4/6/04  
Periostat (doxycycline hyclate) Tablets,  20 mg., Rx CollaGenex Pharmaceuticals NDA 50-783 2/2/01 3/30/01 3/30/01 3/5/02
  PerioStat Indication: Provides for the use of Periostat (doxycycline hyclate, USP) Capsules, 20 mg as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.
Permax (pergolide mesylate) Tablets, Eli Lilly and Company NDA 19-385/S30, S31 & S35 10/2/03  10/9/03  10/10/03  
Permax (pergolide mesylate) Tablets, 0.05, 0.25 and 1.0 mg Eli Lilly and Company NDA 19-385/S-028 8/29/02 9/11/02    
Permax (pergolide mesylate) Tablets, 0.05, 0.25 and 1.0 mg Eli Lilly and Company NDA 19-385/S-028, S-030   3/8/02    
Permethrin Cream, 5%, Rx Clay-Park Labs, Inc. ANDA 76-369 4/21/03      
Permethrin Cream, 5% [1 MB] Alpharma, U.S. Pharmaceuticals Division ANDA 74-806 1/23/98     4/15/98
Permethrin Lotion, 1%, OTC Clay-Park Labs, Inc. ANDA 76-090 12/20/01      
Permethrin Lotion,1%, OTC Alpharma, U.S. Pharmaceuticals Div. ANDA 75-014 3/28/00 4/4/00   8/6/03
Perphenazine Tablet, Rx Vintage Pharmaceutical ANDA 40-226 12/31/98     8/1/03
Perphenazine Oral Solution USP,16 mg/5 mL, Rx Pharmaceutical Associates, Inc. ANDA 40-360  5/25/01 6/5/01    
Phenergan w/dextromethorphan (promethazine HCl & dextromethorphan hydrobromide) Syrup,  Wyeth Pharmaceuticals NDA 11-265/S28 1/16/04 1/22/04    
Phenergan (promethaszine HCl) Syrup and Fortis,  Wyeth-Ayerst Research NDA 8-381/S-026 and S-027 6/27/03 7/6/03    
Phentermine Hydrochloride Capsules USP, 37.5 mg, Rx Mutual Pharmaceutical ANDA 40-527 10/23/03      
Phentermine Hydrochloride Capsules USP, 37.5 mg, Rx Mutual Pharmaceutical ANDA 40-526 10/23/03      
Phentermine Hydrochloride Capsules USP, 30 mg, Rx Mutual Pharmaceutical ANDA 40-525 10/23/03      
Phentermine Hydrochloride Capsules USP, 15 mg, Rx Able Laboratories, Inc. ANDA 40-497 3/13/03      
Phentermine Hydrochloride Capsules USP, 15 mg, Rx Amide Pharmaceuticals, Inc. ANDA 40-460 1/14/03      
Phentermine Hydrochloride Capsules USP, 30 mg, Rx Amide Pharmaceutical, Inc. ANDA 40-448 1/22/03      
Phentermine Hydrochloride Capsules USP, 30 mg, Rx Able Laboratories Inc. ANDA 40-427 8/30/01 4/10/03    
Phentermine Hydrochloride Capsules USP, 30 mg, Rx Able Laboratories Inc. ANDA 40-403 8/30/01 4/9/03    
Phentermine Hydrochloride Capsules USP, 37.5 mg, Rx Able Laboratories Inc. ANDA 40-402 8/30/01 4/9/03    
Phentermine Hydrochloride Tablets USP, 37.5 mg, Rx Vintage Pharmaceuticals, Inc. ANDA 40-377 1/4/02 1/24/02    
Phentermine Hydrochloride Tablets USP, 37.5 mg Purepac Pharmaceutical Co. ANDA 40-276 11/25/98 11/30/98    
Phentolamine Mesylate Injection USP, 5 mg/vial Bedford Laboratories ANDA 40-235 3/11/98     3/15/99
Phentolamine Mesylate Injection USP, 5 mg/vial Bedford Laboratories NDA 40-235 3/11/98     2/18/99
Phenytoin Oral Suspension USP, 125 mg/5 mL, Rx Taro Pharmaceutical ANDA 40-521 3/8/04      
Phenytoin Oral Suspension USP, 125 mg/5 mL, Rx Morton Grove Pharmaceuticals, Inc. ANDA 40-420 4/19/02 4/9/03    
Phenytoin Oral Suspension USP, 125 mg/5 mL, Rx UDL Laboratories, Inc. ANDA 40-342 1/31/01 2/27/01    
Phenytoin Sodium Capsules Extended USP, 100 mg. Mylan Pharmaceuticals Inc. ANDA 40-298 12/28/98 12/28/98 05/09/03  12/23/03
Pherengan (promethazine HCl) Tablets, Rx Wyeth-Ayerst Laboratories NDA 7-935/S-025, S-026, &  S-028  12/26/02 1/29/03    
Pherengan (promethazine HCl) Suppositories, 50 mg., Rx Wyeth-Ayerst Laboratories NDA 11-689/S-016, S-018, S-019, &  S-020 12/26/02 1/29/03    
Pherengan (promethazine HCl) Suppositories, 12.5 mg and 25 mg., Rx Wyeth-Ayerst Laboratories NDA 10-926/S-017, S-020, S-021, and S-022 12/26/02 1/29/03    
PhosLo (calcium acetate) Tablets & Gelcaps, Rx Nabi Biopharmaceuticals NDA 19-976/S6 1/2/04      
PhosLo (calcium acetate) Tablets., Rx Braintree Laboratories, Inc.  NDA 19-976/S-005 11/4/02 11/18/02    
PhosLo Gelcaps and Capsules, Rx Braintree Laboratories NDA 21-160 4/2/01 4/9/01 4/9/01 3/5/02
  PhosLo Indications:  for the control of hyperphosphatemia in end stage renals failure.
Photofrin (porfimer sodium) Injection,  Axcan Scandipharm NDA 21-525 & 20-451/S12 8/1/03 8/15/03 8/15/03  
Photofrin/porfimer sodium Injection, 75 mg vial QLT Phototherapeutics NDA 20-451/S002 1/9/98 5/6/98    
Photofrin (porfimer sodium) Injection, for Injection, Rx QLT Phototherapeutics Inc. NDA 20-451/S003 12/22/98 12/22/98    
  Photofrin Indications: S-003- For use in photodynamic therapy (PDT)  for reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).
Phrenilin w/Caffeine & Codeine (Butalbital, Acetaminophen, Caffeine, & Codeine Phosphate), Rx Amarin Pharmaceuticals, Inc. ANDA 74-911 8/22/01 4/9/03    
Physiolyte (Physiological Irrigating Solution), B. Braun Medical NDA 19-024/S15 10/22/03 10/28/03    
Piperacillin Injection, Rx American Pharmaceutical ANDA 65-114 11/14/03
Pipracil (piperacillin sodium) Intravenous and Intramuscular, Wyeth Pharmaceuticals NDA 50-545/S50 4/2/04 4/7/04    
Pitocin (oxytocin) Injection USP, Rx King Pharmaceuticals, Inc. NDA 18-261/S-023 3/24/03 3/26/03    
Pitocin (oxytocin) Injection USP, Rx Parkedale Pharmaceuticals, Inc. NDA 18-261/S-021 1/10/02 2/8/02    
Plan B (Levonorgestrel) Tablets, 0.75 mg Women's Capital Corporation NDA 21-045 7/28/99     7/26/01
PLASMA-LYTEŽ 56 (Electrolyte Solution), 3% and 5% Sodium Chloride Injections, PLASMA-LYTEŽ Injection, PLASMA-LYTEŽ 148, Ringer's Injection, Lactated Ringer's Injection & 0.9% Sodium Chloride Injection,  Baxter Healthcare Corporation NDA 19-047/S-018, 19-022/S-017, 18-016/S-049, 17-438/S-051, 17-378/S-055, 16-693/S-084, 16-682/S-092 & 16-677/S-124 4/3/02 4/16/02    
Platinol (cisplatin for injection, USP) and Platinol-AQ (cisplatin injection). Bristol-Myers Squibb Company 18-057/S-076 11/8/02 11/19/02    
Plavix (clopidogrel bisulfate) Tablets, Rx Sanofi-Synthelabo Inc. NDA 20-839/S21 & S24 9/29/03  10/9/03    
Plavix (clopidogrel bisulfate)