New Drug Approval Packages

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FDA/Center for Drug Evaluation and Research

These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office. The packages have been redacted or edited to remove confidential information. Click on the product name to view the approval packages in Adobe Acrobat format. For further information about Adobe Acrobat and download instructions, click here.

New Drug Approvals-1997
Product Name--Trade/Generic	Company	Application No.	Approved	Posted
Aceon Capsules/Perindoppril Erbumine 2 mg, 4mg and 8 mg [940 KB]	Rhone Poulenc Roher	020184/S003	1/8/1997	3/20/1998
Acephen	G & W Labs	018060/S55	03/31/1997	9/11/2003
Acular PF/Ketorolac Tromethamine [5.5 MB]	Hoffman-LaRoche	020811	11/3/1997	3/20/1998
Alesse	Wyeth-Ayerst Laboratories	020683	3/27/1997	8/13/03
Allegra-D/Fenofenadine/pseudoephedrine Approval Letter, Medical Review [3.2 MB] Chemistry Review(s), EA (Fonsi) [2.4 MB] Pharmacology Review(s), Statistical Review(s), Clinical Pharmacology Biopharmaceutics Review(s), & Administrative Documents [4 MB	Hoechst Marion Roussel	20786	12/24/1997	10/20/1998
Ambisome Liposome/Amphotericin B for Injection Part 1-Approval Letter, Medical Review [7.6 MB] Part 2a Medical Review [4.2 MB] Part 2b Medical Review [4.7 MB] Part 3 Medical Review/EA/FONSI [3.1 MB] Part 4 Pharmacology Review [4 MB] Part 5 Statistical Review [3.5 MB] Part 6 Microbiology Review [5.3 MB] Part 7 Administrative Documents [1 MB]	Fujisawa, USA	050740	8/17/1997	10/29/1998
Amikacin Sulfate in 0.9% Sodium Chloride Injection [821 KB]	Abbott Laboratories	64146	04/02/1997	5/18/2001
Ampicillin/Sulbactam IM/IV [7.2 MB]	Pfizer, Inc.	050608/S019	2/12/1997	2/6/1997
Androderm (Testosterone Transdermal System)	TheraTech, Inc.	20-489/S003	5/2/1997	9/18/1997
Anzemet Tablets/Dolasetron mesylate Approval Letter [791 KB] Medical Review(s) Part 1 [4.1 MB],+ Part 2 [3.4 MB] Part 3 [4 MB] Part 4 [5.2 MB] Part 5 [4.2 MB] Part 6 [3.3 MB] Part 7[4.6 MB] Part 8 [4.1 MB] Part 9 [3.2 MB] Part 10 [4.5 MB] Part 11 [4.4 MB] Chemistry Review(s) & EA(Fonsi) [4.9 MB] Pharmacology Review(s) Part 1 [5.3 MB], Part 2 [5.3 MB] & Part 3 [3.6 MB] Statistical Review(s) Part 1 [5.3 MB] & Part 2 [5.3 MB] Clinical Pharmacology Biopharmaceutics Review(s) Part 1 [3.4 MB] & Part 2 [4.2 MB] Administrative Documents Part 1 [4.9 MB] & Part 2 [4.5 MB] Correspondence [180 KB]	Hoescht Marion Roussel, Inc.	020623	9/11/1997	10/20/1998
Anzemet Injection/Dolasetron Mesylate Approval Letter [602 KB] Medical Review(s) Part 1 [3.6 MB],+ Part 2 [3.7 MB] Part 3 [4.5 MB] Part 4 [4.2 MB] Part 5 [4.4 MB]] Chemistry Review(s) & EA(Fonsi) Pharmacology Review(s) [3.7 MB] Statistical Review(s) & Microbiology Reviews [5.1 MB] Clinical Pharmacology Biopharmaceutics Review(s) Part 1 [3.5 MB] & Part 2 [4.1 MB] Administrative Documents & Correspondence [3.3 MB]	Hoescht Marion Roussel, Inc.	020624	10/11/1997	10/20/1998
Arthrotec (Diclofenac Sodium/Misoprostol) Tablets, Part 1, Part 2, Part 3, Part 4, Part 5, Part 6, Part 7, Part 8, Part 9, Part 10, Part 11,	G.D. Searle and Company	020607	12/24/1997	4/30/2002
Asacol Mesalamine	Procter and Gamble	019651/S005	8/19/1997	6/18/2003
Ativan/Lorazepam [11.8 MB]	Wyeth-Ayerst Laboratories	018140/S003	10/5/1997	12/17/1997
Avapro/Irbesartan and Irbesartan and Hydrochlorothiazide Approval Letter [210 KB] Medical Letter Part 1 [4.9 MB], Part 2 [4 MB] Part 3 [4 MB], Part 4 [3.8 MB] Chemistry Review(s) & EA(Fonsi) [4.1 MB] Pharmacology Review(s) Part 1 [4.5 MB], Part 2 [5.1 MB] Part 3 [3.9 MB], Part 4 [2 MB] Statistical Review(s) & Administrative Documents [914 KB]	Sanofi Pharmaceuticals.	20757/20758	9/30/1997	5/19/1998
Avita cream 0.025%/Tretinoin cream Part 1 [6 MB] Part 2 [7.3 MB]	Penederm, Inc.	020404	1/14/1997	2/4/1998
Bactroban	SmithKline Beecham Pharmaceuticals	050746	12/11/1997	8/13/2003
Baycol 0.05, 0.1, 0.2 & 0.3 MG/Cervistatin Sodium Tablets Approval Letter [279 KB] Medical Review(s) Part 1 [4 MB] & Part 2 [4.8 MB] Chemistry Review(s) & EA(Fonsi) [1.6 MB] Pharmacology Review(s) Part 1 [2.2 MB] & Part 2 [3.3 MB] Statistical Review(s) Part 1 [3.2 MB] & Part 2 [4.7 MB] Clinical Pharmacology Biopharmaceutics Review(s) Part 1 [3.4 MB] & Part 2 [2.2 MB] Administrative Documents & Correspondence [1.2 MB]	Bayer Corporation Pharmaceutical Division	020740	6/26/1997	5/18/1998
Carbatrol/Carbamazepine extended release capsules Part 1 [8.9 MB] Part 2 [7.3 MB]	Shire Laboratories	020712	10/30/1997	12/17/1997
Cardizem Monovial/Diltiazem [3.5 MB]	Hoechst Marion Roussel	020792	10/7/1997	12/17/1997
Caverject	Pharmacia & Upjohn	020755	10/31/1997	8/13/2003
Cholestyramine Oral Suspension	Baker Norton Pharmaceuticals, Inc.	74771	7/9/1997	9/28/01
Climara (estradiol transdermal system)	3M Pharmaceuticals	20375 - S7	09/16/1997	8/11/2003
Clinimix E sulfite-free Injections in Clarity Dual Chamber Container/Amino Acid with Electolytes in Dextrose with Calcium [3 MB]	Baxter Healthcare Corporation	020678	3/26/1997	11/17/1997
Cognex/Tacrine Hydrochloride [1.6 MB]	Parke-Davis Pharm.	020070/S004 S006	10/10/1997	3/20/1998
Cordarone (amiodarone HCI) I.V., 50 mg/ml in 3 ml vial	Wyeth-Ayerst Laboratories	20377 - S2	12/10/1997	8/11/2003
Corlopam/Fenoldopam Mesylate Approval Letter [169 KB] Medical Review Part 1 [4.2 MB] Part 2 [5 MB] Part 3 [4.8 MB] Chemistry Review & EA/FONSI [1.9 MB] Pharmacology Review Part 1 [3.3 MB] Part 2 [2.3 MB] Statistical Review & Microbiology Review [697 KB] Clinical Pharmacology Biopharmaceutics Review [3.7 MB] Administrative Documents [1.7 MB]	Neurex Corp.	019922	9/23/1997	3/23/1998
Cozaar and Hyzaar/Losartan Potassium and Hydrochlorothiazide [1.2 MB]	Merck Research Lab.	20386/S007 20387/S005	11/7/1997	3/20/1998
Crinone	Columbia Research Laboratories	020701	7/31/1997	8/13/2003
Crinone	Columbia Research Laboratories	020756	5/13/1997	8/13/2003
Crixivan capsules/Indinavir sulfate [869 KB]	Merck Research Laboratories	020685/S005	2/19/1997	11/25/1997
Cylert Tablets/Pemoline	Abbott Laboratories	16832/S013	12/12/1997	10/23/1998
Cylert Tablets/Pemoline	Abbott Laboratories	16832/S015	12/12/1997	10/23/1998
Cytovene/Gancoclovir [1 MB]	Roche Global Development	20460/S008	12/12/1997	10/20/1998
Demadex/Torsemide [3.7 MB]	Boehringer Mannheim	020136/S009 020137/S008	10/9/1997	12/17/1997
Dovonex Scalp Solution 0.005%/Calcipotriene solution [5.4 MB]	Bristol-Myers Squibb Pharmaceutical Research Institute	020611	3/3/1997	11/21/1997
Duract/Bromfenac Sodium Approval/Approvable Letters [370 KB] Medical Review(s) Part 1 [4.1 MB] Part 2 [3.1 MB] Part 3 [2.9 MB] Chemistry Review/EA(FONSI) [1.4 KB] Pharmacology Review(s) [3.9 MB] Clinical Pharmacology Biopharmaceutics Review(s) Part 1 [4.1 MB] Part 2 [2.7 MB] Statistical Review(s) [1.8 MB] Administrative Documents [604 KB]	Wyeth-Ayerst Laboratories	020535	7/13/1997	5/11/1998
Dynabac (Dirithromycin Tablets) Approval Letters [250 KB] Medical Review(s) Part 1 [10 MB] Part 2 [10 MB] Statistical Review(s) [3.4 MB] Microbiology Reviews, Clinical Pharmacology Biopharmaceutics Review(s), & Administrative Documents [2.3 MB]	Lilly Research Laboratories	50678/SE1003	12/19/97	7/12/00
Edex	Schwarz Pharma	020649	06/12/1997	8/12/2003
Effexor XR/Venlafaxin Hyrochloride Approval/Approvable Letters [351 KB] Medical Review(s) Part 1 [4.1 MB] Part 2 [4.6 MB] Chemistry Review(s), EA(Fonsi), & Pharmacology Review(s) [1.9 MB] Statistical Review(s) [2.5 MB] Clinical Pharmacology Biopharmaceutics Review(s) & Administrative Documents [3.9 MB]	Wyeth-Ayerst Laboratories	20699	10/20/1997	5/13/1998
Eldepryl/Selegiline, 5 mg	Somerset Pharmaceuticals	20647/ S001, S002, S003	8/6/1997	10/23/1998
Emadine/Emedastine difumarate Approval Letter [265 KB] Medical Review(s) [2.1 MB] Chemistry Review(s) EA(Fonsi) & Pharmacology Review(s) [3.7 MB] Statistical Review(s) [2.7 MB] Clinical Pharmacology Biopharmaceutics Review(s) & Administrative Documents [1.2 MB]	Alcon Laboratories	20706	12/29/1997	10/20/1998
Evista 60 MG Tablets/Raloxifene Hydrochloride Part 1 [10.5 MB] Part 2A [2.3 MB] (Clin. Pharm. & Biopharm. Rev.) Part 2B [2.7 MB] (Clin. Pharm. & Biopharm. Rev. con't) Part 3 [9.9 MB] (Pharmacology Reviews) Part 4 [7.2 M] (Statistical Reviews)	Lilly Research Laboratories	020815	12/09/1997	02/19/1998
Femara	Novartis Pharmaceuticals	020726	7/25/1997	8/13/2003
FerriSeltz/Ferric Ammonium Citrate, Brown Part 1 [11.4 MB] Part 2 [8.1 MB]	Oncomembrane, Inc.	020292	10/14/1997	2/4/1998
Flagyl ER 750 mg tablets	G.D. Searle and Company	020868	11/26/1997	2/4/1998
Flomax 0.4 mg capsules/Tamsulosin hydrochloride [16.5 MB]	Boehringer Ingelheim Pharmaceuticals, Inc.	020579	4/15/1997	11/17/1997
Flonase/Fluticsone propionate Part 1 [2.7 MB] Part 2 [3.6 MB]	Glaxo Wellcome Inc.	20121/S005	10/31/1997	10/20/1998
Flovent Rotadisk/Fluticasone Propionate [7.9 MB]	Glaxo Wellcome	020549 020770	11/7/1997	3/20/1998
Flucinonide Ointment USP	Altana, Inc.	74905	8/26/1997	9/28/01
Follistim	Organon	020582	09/29/1997	8/11/2003
Fortovase/Saquinavir Approval Letter [181 KB] Medical Review(s) Part 1 [2.3 MB], & Part 2 [3.5 MB] Chemistry Review(s), Environmental Assessment and/or FONSI, Pharmacology Review(s) [2.5 MB] Statistical Review(s), Clinical Pharmacology & Biopharmaceutics Review(s), Administrative Document(s) [1.9 MB]	Hoffman-LaRoche	020828	11/7/1997	5/11/1998
Fosamax Tablets/Alendronate Sodium [10 MB]	Merck Research Laboratories	020560/S03 020560/S06	4/25/1997	12/5/1997
Gabitril/Tiagabine Hydrochloride Approval/Approvable Letter [677 KB] Medical Review(s) Part 1 [4.2 MB] Part 2 [3.6 MB] Part 3 [3.5 MB] Part 4 [4.1 MB] Chemistry Review(s)/EA(Fonsi) [4.1 MB] Pharmacology Review(s) [4.7 MB] Statistical Review(s) [5.4 MB] Bioequivalence Review(s) [1 MB] Administrative Documents [1 MB]	Abbott Laboratories	20646	9/30/1997	5/12/1998
Galzin Capsules/Zinc Acetate Capsules [13.9 MB]	Lemon Company	020458	1/28/1997	12/11/1997
GenESA/Arbutamine Part 1 [6.9 MB] Part 2 [7.5 MB] Part 3 [2.6 MB] Part 4 [12.4 MB] Part 5 [1.3 MB]	Gensia Automedics	020420	9/12/1997	12/18/1997
Genotropin Approval Letter [299 KB] Medical Review Part 1 [5 MB] Part 2 [4.4 MB] Part 3 [3 MB] Chemistry Review [113 KB] Pharmacology Review/Statistical Review [1 MB] Clinical Pharmacology & Biopharmaceutics Review/Bioequivalence Review [1 MB] Administrative Documents/Correspondence Documents [2.1 MB]	Pharmacia and Upjohn, Inc.	020280/S008	10/31/1997	5/8/1998
Glucophage Tablets/Metformin Hydrochloride [1.2 MB]	Bristol-Myers Squibb Company	020357/S006	11/6/1997	3/17/1998
Glynase Prestabs/Micronized Glyburide 1.5 mg, 3 mg, and 6 mg [295KB]	Pharmacia and Upjohn Co.	020051/S008	1/10/1997	3/20/1998
Humalog/Insulin Lispro (rDNA Origin) Injection [2 MB]	Eli Lilly and Company	020563/S003	07/16/1997	5/11/1998
Humatrope/Somatropin (rDNA orgin) [13.3 MB]	Eli Lilly and Company	019640/S018 019640/S019	3/11/1997	11/7/1997
Hydralazine	Company: Luitpold Pharmaceutical	Application No.: 040136	06/30/1997	8/1/2003
Imitrex/Sumatriptan Part 1 [8.4 MB] Part 2 [10.3 MB] Part 3 [6.2 MB]	Glaxo Wellcome	020626	8/26/1997	12/17/1997
Imodium A-D	McNeil	020448	07/24/1997	8/11/2003
Imodium Advanced Chewable Tablets/Loperadmide HCl/Simethicone [8 MB]	McNeil Consumer Products Company	020606	6/25/1997	11/26/1997
Invirase Capsules/Saquinavir Mesylate Capsules [945 KB]	Hoffman-La Roche Inc.	020628/S007	2/27/1997	12/5/1997
Kadian Sustained Release Capsules (morphine sulfate) 20 mg, 50 mg & 100 mg [2.2 MB]	F.H. Faulding and Company Limited		7/29/1997	6/12/2000
Ketorolac Tromethamine Tablets, USP, 10 mg	Lemmon Company	74754	5/16/1997	8/27/2001
Kytril tablets/Gramosetron Hydrochloride [9.3 MB]	SmithKline Beecham Pharmaceuticals	020305/S001	10/6/1997	2/4/1998
Lamisil	Novartis Pharmaceuticals	020749	10/17/1997	8/13/2003
Lamisil Cream 1%/Terbinafine Hydrochloride Cream [3 MB]	Sandoz Pharmaceuticals Co.	020193/S003	1/21/1997	11/17/1997
Lanoxin/Digoxin Approval Letter [205 KB] Medical Review(s) & Chemical Review(s) [4 MB] Enviormental Assessment (Fonsi) [4 MB] Pharmacology Review(s) & Clinical Pharmacology Biopharmaceutics Review(s) [1.7 MB] Administrative Document(s) [913 KB]	Glaxo Wellcome	020405	9/30/1997	3/23/1998
Lansoprazole/Clarithromycin/Amoxicillin [3.3 MB]	Tap Holdings, Inc.	050757	12/2/1997	2/6/1998
Lente Purified Pork Insulin Zinc Suspension USP [1 MB]	Novo Nordisk Pharmaceuticals, Inc.	018383/S025	4/16/1997	11/20/1997
Lipitor Tablets/Atorvastatin Calcium [525 KB]	Parke-Davis	20702/S002	11/28/1997	10/20/1998
Lisinopril Tablets [8.9]	Zeneca Pharmaceuticals	019777/S032	1/8/1997	2/6/1998
Locoid	Inveresk Research	020769	9/08/1997	8/13/2003
Lotrel (Amlodipine Besylate/Benazepril Hydrochloride) Capsules	Novartis Pharmaceuticals Corporation	20-364/S007	3/14/1997	9/18/01
Lupron	TAP Holdings	020708	3/07/1997	8/13/2003
Lupron Depot, 4 month, 30 mg/Leuprolide acetate [7 MB]	TAP Holdings, Inc.	020517/S002	5/30/1997	11/17/1997
Mevacor Tablets/Lovastatin	Merck and Company, Inc.	019643/S050	8/12/1997	10/20/1998
Mevacor Tablets/Lovastatin	Merck Research Laboratories	019643/S051/S053	6/25/1997	10/20/1998
Mavik 1 mg, 2 mg and 4 mg Tablets [4.6 MB]	Knoll Pharmaceutical Company	020528/S-001	7/2/1997	11/21/1997
Maxipime for Injection	Bristol-Myers Squibb	050679/S-002	5/16/97	8/2/99
Meridia Capsules 5mg, 10 mg, 15 mg/Sibutramine Hydrochloride Monohydrate Part 1-Approval Letter, Medical Review [8.6 MB] Part 2-Medical Review [7.6 MB] Part 3-Chemistry and Pharmtox Review [5.4 MB] Part 4-Pharmtox Review [7 MB] Part 5-Statistical Review [9.7 MB] Part 6-Administrative Documents [7.4 MB] Part 7-Administrative Documents [10 MB] Part 8-Administrative Documents [6.9 MB]	Knoll Pharmaceutical Company	020632	11/22/1997	3/4/1998
Miacalcin Injection/Calcitonin Salmon [373 KB]	Novartis Pharmaceutical Corp.	017808/S014	7/14/1997	3/17/1998
Migranal/Dihydroergotamine mesylate Approval Letter [195 KB] Medical Review(s) [4.8 MB] Chemistry Review(s) & EA(Fonsi) [2.8 MB] Pharmacology Review(s) Part 1 [3 MB] & Part 2 [3.2 MB] Statistical Review(s) & Administrative Documents [1.5 MB]	Novartis Pharmaceuticals	20148	12/08/1997	10/20/1998
Mirapex .125 mg, .25 mg, 1 mg, 1.25 mg and 1.5 mg tablets/Pramipexole dihyrochloride [29 MB]	Pharmacia and Upjohn, Inc.	020667	7/1/1997	11/17/1997
Nasonex/Mometasone Furoate Approval Letter [714 KB] Medical Review(s) Part 1 [4.6 MB], Part 2 [3.4 MB], Part 3 [4.1 MB], Part 4 [4 MB], Part 5 [3.5 MB], Part 6 [4.2 MB] Chemistry Review(s) & EA(Fonsi) [1.4 MB] Pharmacology Review(s) Part 1 [3 MB], Part 2 [3.7 MB] Statistical Review(s), Microbiology Review(s), & Clinical Pharmacology Bioequivalence Review(s) [1.7 MB] Administrative Documents [714 KB]	Schering Corp.	20762	10/1/1997	5/19/1997
Nicotrol	Pharmacia and Upjohn	020714	5/02/1997	8/13/2003
Nizoral A-D (Ketoconazole) Shampoo	Johnson & Johnson Consumer Products Inc.	20310	10/10/1997	9/28/01
Noritate	Dermik Laboratories	020743	9/26/1997	8/13/2003
Norvasc (amlodipine besylate) Tablets	Pfizer Inc.	19787-S15	5/16/1997	8/6/2003
Norvasc (amlodipine besylate) Tablets	Pfizer Inc.	19787-S14	4/18/1997	8/6/2003
Novolin 70/30/Human Insulin (rDNA origin) [1 MB]	Novo Nordisk Pharmaceuticals, Inc.	019991/S021	4/16/1997	11/20/1997
Novolin N/Human Insulin (rDNA origin) [1 MB]	Novo Nordisk Pharmaceuticals, Inc.	019965/S017	4/16/1997	11/20/1997
Novolin N/Human Insulin (rDNA origin) [1 MB]	Novo Nordisk Pharmaceuticals, Inc.	019959/S021	4/16/1997	11/20/1997
Novolin R/Human Insulin (rDNA origin) Injection	Novo Nordisk Pharmaceuticals, Inc.	019938/S019	4/10/1997	10/20/1998
Novolin R/Human Insulin (rDNA origin) [1 MB]	Novo Nordisk Pharmaceuticals, Inc.	019938/S020	11/20/1997	11/20/1997
NPH Purified Pork Isophane Insulin Suspension USP [1 MB]	Novo Nordisk Pharmaceuticals, Inc.	018623/S027	4/16/1997	11/20/1997
Nutropin AQ 10 mg vial/Somatropin (rDNA origin) injection	Genentech, Inc.	020522/S002	3/24/1997	11/17/1997
Nutropin AQ Injection/Somatropin (rDNA origin)	Genetech, Inc.	020522/S004	12/17/1997	10/20/1998
Omnicef (cefdinir) Capsules Approval Letter and Final printed Labeling Medical Reviews medr_P1 medr_P2 medr_P3 medr_P4 medr_P5 medr_P6 Chemistry Reviews and Enviornmental Assessment Clinical Pharmacology and Biopharmaceutics Reviews Microbiology Reviews Pharmacoly Reviews Administrative Documents_Correspondence	Parke-Davis	50739	12/4/97	7/12/00
Omnicef Powder (cefdinir) Oral Suspension Approval Letter and Final printed Labeling Medical Reviews medr_P1 medr_P2 medr_P3 medr_P4 medr_P5 medr_P6 Chemistry Reviews and Enviornmental Assessment Clinical Pharmacology and Biopharmaceutics Reviews Microbiology Reviews Pharmacoly Reviews Administrative Documents_Correspondence	Parke-Davis	50749	12/4/97	7/11/00
Omniscan Injection/Gadodiamide [1.5 MB]	Nycomed Inc.	020123/S015	10/3/1997	3/17/1998
Optiray/Ioversol Injection [499 KB]	Mallinckrodt Medical, Inc.	019710/S021	5/23/1997
Orudis and Oruvail Capsules	Wyeth-Ayerst Laboratories	018754/S25 019816/S07	08/05/1997	9/11/2003
Ovral (Norgestrel & Ethinyl Estradiol) Tablets & Ovral-28 (Norgestrel & Ethinyl Estradiol) Tablets	Wyeth-Ayerst Laboratories	16-672 & 16-806	8/14/1997	9/18/2001
Ovral (Norgestrel & Ethinyl Estradiol) Tablets & Ovral-28 (Norgestrel & Ethinyl Estradiol) Tablets	Wyeth-Ayerst Laboratories	16-672/S047 & 16-806/S029	8/14/1997	9/18/2001
Pitocin (Oxytocin) Injection	Parke-Davis Pharmaceutical Research	18-261/S011	7/29/1997	9/18/2001
Plavix/Clopidogrel bisulfate Approval Letter, Medical Review, Chemistry Review(s), EA (Fonsi), Pharmacology Review(s) [3.4 MB] Clinical Pharmacology Biopharmaceutics Review(s) Part 1 [3 MB] Part 2 [2.6 MB] Administrative Documents [2.8 MB]	Sanofi Pharmaceuticals	20839	11/17/1997	10/20/1998
Pondimin Tablets/Fenfluramine Hydrochloride [620 MB]	Wyeth-Ayerst Laboratories	016618/S041	8/29/1997	3/17/1998
Pravachol Tablets/Pravastatin Sodium [1.2 MB]	Bristol-Myers Squibb Company	019898/S017	4/15/1997	5/7/1998
Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate tablets) [32 MB]	Wyeth-Ayerst Laboratories	20527/S004	7/31/97	7/11/00
Prevacid Delayed-Release Capsules [32 MB]	TAP Holdings, Inc.	20876	6/17/97	6/1/00
Prevacid Delayed-Release Capsules [34 MB] appltr.pdf medr_P1.pdf, medr_P2.pdf, medr_P3.pdf, medr_P4.pdf, medr_P5.pdf, medr_P6.pdf clinphrmr.pdf admindocs.pdf corres_P1.pdf, corres_P2.pdf, corres_P3.pdf, corres_P4.pdf, corres_P5.pdf	TAP Holdings, Inc.	20877	6/17/97	6/1/00
Procardia XL (Nifedipine) Tablets & Norvasc (Amiodipine Besylate) Tablets	Pfizer Inc.	19-684/S012 & 19-787/S013	1/8/1997	9/18/01
Propecia	Merck Research Laboratories	020788	12/19/1997	8/13/2003
Proscar (Finasteride)	Merck Research Laboratories	20-180/S017	12/19/1997	9/18/01
Proscar (Finasteride) Tablets	Merck Research Laboratories	20-180/S013	5/12/1997	9/18/01
Prozac	Lilly Research Laboratories	18-936/S36 & 20-101/S009	3/25/1997	9/25/2003
Ranitidine Capsules, 150 & 300 mg	Geneva Pharmaceuticals, Inc.	74655	10/22/1997	8/27/01
Regular Purified Pork Insulin Injection USP [1 MB]	Novo Nordisk Pharmaceuticals, Inc.	018381/S027	4/16/1997	11/20/1997
Requip/Ropinirole Hydrochloride Approval/Approvable Letter [502 KB] Medical Review(s) Part 1 [4.8 MB], Part 2 [3.9 MB], Part 3 [4.4 MB] Chemistry Review(s)/EA(Fonsi) [4.2 MB] Pharmacology Review(s) Part 1 [4.4 MB], Part 2 [3.2 MB] Statistical Review(s) [3.7 MB] Clinical Pharmacology Biopharmaceutics Review(s) [1.4 MB] Administrative Documents [3.2 MB]	Smithkline Beecham Pharmaceuticals	20658	9/19/1997	5/12/1998
Retin-A Micro Microsphere 0.1%/Tretinoin gel [14 MB]	Advanced Polymer Systems	020475	2/7/1997	11/17/1997
Rezulin 200 mg and 400 mg tablets/Troglitazone [4.7 MB]	Parke Davis Pharmaceutical Research	020720/S002 020720/S003 020720/S005	8/4/1997	11/17/1997
Risperdal/Risperidione [2.4 MB]	Janssen Research	20588/S002 AND 20272/S007	10/17/1997	10/20/1998
Rogaine (Minoxidil Topical Solution) Extra Strength For Men, 5% Approval Letter & Medical Review(s) [1.3 MB] Chemistry Review(s), Pharmacology Review(s), Statistical Review(s) & Bioequivalence Review(s) [3 MB] Administrative Documents & Correspondence [1.7 MB]	Pharmacia & Upjohn Consumer Healthcare	20834	11/14/1997	7/8/1999
Rowasa 500 mg suppository/Mesalamine [565 KB]	Solvay Pharmaceuticals	019919/S002	8/8/1997	2/4/1998
Rythmol/Propafenone [4 MB]	Knoll Pharmaceuticals	19151/S002	12/23/1997	10/29/1998
Sclerosol	Bryan	020587	12/24/1997	8/11/2003
Serevent Diskus/Salmeterol Xinafoate Approval Letter [173 KB] Medical Review(s) Part 1 [5.3 MB] Part 2 [3.8 MB] Chemical Review(s), EA(Fonsi), & Pharmacology Review(s) [2.4 MB] Statistical Review(s) [1.8 MB] Clinical Pharmacology Biopharmaceutics Review(s) & Administrative Documents [1.3 MB]	Glaxo Wellcome Inc.	20692	9/19/1997	5/13/1998
Seroquel/Quetiapine Fumarate Approval Letter [308 KB] Medical Review(s) Part 1 [3 MB] Part 2 [4.2 MB] Part 3 [4.2 MB] Chemistry Review(s)/EA(Fonsi) [1.2 MB] Pharmacology Review(s) Part 1 [3.3 MB], Part 2 [4.2 MB], Part 3 [4.9] Statistical Review(s) [2.3 MB] Administrative Documents [699 KB]	Zeneca Pharmaceuticals	20639	9/26/1997	5/12/1998
Skelid Tablets/Tiludronate Disodium 200mg Tablets Approval/Approvable Letter [159KB] Patent Information, Exclusivity Summary, & Pediatric Studies Pages [475 KB] Medical Review(s) [5 MB] Statistical Review(s) & Clinical Pharmacology Biopharmaceutics Review(s) [3.4 MB] Pharmacology Review(s), Chemistry Review(s), & EA(Fonsi) [3.9 MB] Correspondence [65 KB]	Sanofi Winthrop, Inc.	020707	3/7/1997	5/13/1998
Soriatane (acitretin) Capsules, 10 & 25 mg	Hoffmann-La Roche Inc.	19821S001	6/5/1997	5/25/2001
Statrol	Alcon	50456/S20	09/09/1997	9/11/2003
Tazorac	Allergan	020600	06/13/1997	8/11/2003
Testoderm	Alza	020791	12/18/1997	8/13/2003
Tevetan/Eprosartan mesylate Approval Letter [180 KB] Medical Review(s) Part 1 [4.1 MB], Part 2 [4 MB] Part 3 [4.4 MB] Part 4 [4.2 MB] Part 5 [4.2 MB] Part 6 [3.7 MB] Chemistry Review(s) [312 KB] EA(Fonsi) [1.5 MB] Pharmacology Review(s) Part 1 [2.9 MB] Part 2 [3.1 MB] Statistical Review(s) [2.9 MB] Bioequivalence Review(s) [3.6 MB] Administrative Documents [1 MB]	SmithKline Beecham	20738	12/22/1997	10/20/1998
Tilade Nebulizer Solution/Nedocromil Sodium Inhalation Solution Approval Letter [170 KB] Medical Review(s) [4.4 MB] Chemistry Review(s), EA(Fonsi), & Pharmacology Review(s) [2.5 MB] Statistical Review(s) & Microbiology Review(s) [2.5 MB] Clinical Pharmacology Biopharmaceutics Review(s) [1.2 MB] Administrative Documents [1 MB]	Rhone-Poulenc Rorer	02750	10/1/1997	5/18/1998
Timoptic	Merck	018086/S47	05/16/1997	9/11/2003
TOBI/Tobramycin Solution for Inhalation Approval Letter and Medical Review Environmental Assessment, FONSI, Pharmacology Microbiology Review	PathGenesis Corporation	50753	12/22/1997	2/4/1999
Total toothpaste/Triclosan/sodium fluride Part 1 [3.4 MB] Part 2 [3.7 MB]	Colgate-Palmolive	20231	7/11/1997	10/20/1998
Trental tablets/Pentoxifylline [0.4 MB]	Hoescht Marion Roussel	018631/S030	4/29/1997	11/17/1997
Trovan Tablets and Trovan IV/trovafloxacin mesylate Approval Package	Pfizer	20-759 & 20760	12/18/1997	10/26/1998
Urso (Ursodiol) Tablets Approval Package	Axcan pharma U.S. Inc.	020675	12/10/97	3/14/00
Vagistat-1	Bristol-Myers Squibb	020676	2/11/1997	8/13/03
Valtrex/Valacyclovir Hydrochloride [4.3 MB]	Glaxo Wellcome	20550/S003	9/26/1997	3/20/1998
Vaseretic Tablets/Enalapril maleate-Hydrochlorothizide [865 KB]	Merck Research Laboratories	019221/S023	6/11/1997	11/20/1997
Vasotec I.V. and Tablets/Enalapriilat and Enalapril maleate [ 1.3 MB]	Merck Research Laboratories	019309/S021 018998/S053	6/11/1997	11/20/1997
Velosulin BR Buffered Regular Human Insulin/Human Insulin (sem-synthetic) [1 MB]	Novo Nordisk Pharmaceuticals, Inc.	019450/S017	4/16/1997	11/20/1997
Versed/Midazolam Hydrochloride [3.7 MB]	Hoffman-La Roche Inc.	018654/S018 S029 S030	11/31/1996 3/18/1997	11/20/1997
Vicoprofen/Hydrocodone Bitartrate/Ibuprofen Approval Letter [149 KB] Medical Review(s) Part 1 [3 MB], Part 2 [2.8 MB] Chemistry Review(s), EA(Fonsi), Pharmacology Review(s), & Statistical Review(s) [4 MB] Clinical Pharmacology Biopharmaceutics Review(s) [2.4 MB] Administrative Documents [538 KB]	Knoll Pharmaceutical Co.	20716	9/23/1997	5/15/1998
Viracept oral powder 50 mg/g/Nelfinavir mesvlate [16.5 MB]	Agouron Pharmaceuticals, Inc.	020778	3/14/1997	11/17/1997
Viracept tablets 250 mg/Nefinavir mesvlate [16.5 MB]	Agouron Pharmaceuticals, Inc.	020779	3/14/1997	11/17/1997
Visipaque Injection Parenteral 270 mgI/mL/Iodixanol Approval Letter [309 KB] Label (10/26/98) Medical Review(s) Part 1 [4.8 MB] & Part 2 [4.2 MB] Chemical Review(s) & Clinical Pharmacology Biopharmaceutics Review(s) [2 MB] Administrative Document(s) [677 KB]	Nycomed, Inc.	020351/S01/S03	10/10/1997	5/11/1998
Wellbutrin/Buproion HCL SR Tablets	Glaxo Wellcome	20-358 S001/S003	12/16/1997	10/23/1997
Zebeta (Bisoprolol Fumarate) Tablets, 5 & 10 mg	Wyeth-Ayerst Laboratories	19-982/S004	1/14/1997	8/1/2001
Zithromax injection/Azithromycin for intraveneous injection [9.9 MB]	Pfizer, Inc.	050733	1/30/1997	11/17/1997
Zocor/Simvastatin Tablets	Merck	19766/S018	5/19/1997	10/23/1998
Zofran (Ondanstron HCL) Injection & Injection Premixed	GlaxoWellcome Inc.	NDA 20-007/S022 & 20-403/S005	10/31/1997	4/30/2002
Zofran Solution 4mg/5ml/Ondansetron [2.4 MB]	GlaxoWellcome	020605	1/24/1997	2/4/1998
Zoladex (Goserelin Acetate Implant) Depot, 3.6 mg	Zeneca Pharmaceuticals, Inc.	19726S18	6/27/1997	10/3/01
Zoloft 25 mg, 50 mg, and 100 mg Tablets/Sertaline HCl [7 MB]	Pfizer, Inc.	019839/S011	7/8/1997	11/20/1997
Zoloft/Sertaline HCl [5.6 MB]	Pfizer, Inc.	019839/S017 S018	10/10/1997	3/20/1998
Zomig/Zolmitriptan Approval Letter [163 KB] Medical Review(s) Part 1 [3.2 MB] & Part 2 [4.3 MB] Chemical Review(s), & EA(Fonsi) [1 MB] Pharmacology Review(s) Part 1 [4 MB], Part 2 [2.4 MB], Part 3 [3.1 MB] Statistical Review(s) & Clinical Pharmacology Biopharmaceutics Review(s) [1.6 MB] Administrative Document(s) [2 MB]	Zeneca Pharmaceuticals	20768	11/25/1997	5/19/1998
Zovirax Ointment/Acyclovir, 5%	Glaxo Wellcome, Inc.	018604/S014	1/08/97	7/14/99
Zyban	Glaxo Wellcome	020711	5/14/1997	8/13/2003

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