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 |