New Drug Approvals-1996 and Older |
| Product Name--Trade/Generic |
Company |
Application No. |
Approved |
Posted |
Acetic Acid
|
Morton Grove Pharmaceuticals |
040166 |
07/26/1996 |
8/1/2003 |
| Actron |
Bayer |
020499 |
10/06/1995 |
8/11/2003 |
| Adderall Tablets 10 mg & 20 mg [10.5 MB] |
Richwood Pharmaceutical Company |
11522/S010 |
2/13/1996 |
6/12/2000 |
| Anectine (succinylcholine chloride) Injection [23 MB] |
Burroughs Wellcome Company |
8453/S-001, S-004, S-006, S-012 |
6/22/1973 |
6/12/2000 |
| Aphthasol Oral Paste 5%/Amlexanox Oral Paste [12.8 MB] |
Block Drug Company |
020511 |
12/17/1996 |
11/20/1997 |
Aredia Pamidronate Sodium
Label
Letter |
Novartis |
20036 |
10/31/1991 |
12/2/2003 |
| Augmentin (amoxicillin/clavulanate) [3.7 MB] |
SmithKline Beecham |
50564/S-022, 50575/S-016, 50579/S-020 |
2/16/96 |
8/2/1999 |
| Azelex Cream (azelaic acid) 20% [8 MB] |
Allergan Herbert Division of Allergan, Inc. |
20428/S-001, S-007 |
5/17/1996 |
6/12/2000 |
| Benzedrine (Amphetamine Sulate) Tablets, 5 mg & 10 mg |
Smith Kline & French Laboratories |
83900 |
2/26/1976 |
12/6/2001 |
| Biaxin (Clarithromycin) Tablets [783 KB] |
Abbott Laboratories |
50662/S-013 |
12/20/96 |
8/2/1999 |
| Blenoxane (Sterile Bleomycin Sulfate, USP) 15 & 30 Unit Vials [248 KB] |
Bristol-Myers Squibb |
50443/S026 |
9/30/96 |
8/2/1999 |
| Butenafine HCI Cream [6.3] |
Penederm, Inc. |
020663 |
12/31/1996 |
2/6/1998 |
| Carnitor Tablets/Levocarnitine [640 KB] |
Sigma-Tau Pharmaceuticals, Inc. |
018948/S016 |
7/14/1992 |
5/7/1998 |
Catapres-TTS (clonodine hydrochloride) Transdermal Therapeutic System |
Boehringer Ingelheim Pharmaceuticals, Inc. |
18891-S15 |
9/6/96 |
8/5/2003 |
| Cefotan/cefotetan disodium injection [1.8 MB] |
Zeneca Pharmaceuticals |
50694 |
7/30/1993 |
3/4/1999 |
| Cerebyx Injection |
Parke Davis |
020450/S1 |
12/26/1996 |
6/17/2003 |
| Claritin Tablets |
Schering |
19658/S005 |
2/15/94 |
5/25/01 |
| Climara (estradiol transdermal system) |
3M Pharmaceuticals |
20375 - S5 |
05/17/1996 |
8/11/2003 |
| Climara (estradiol transdermal system) |
3M Pharmaceuticals |
20375 - S4 |
10/10/1995 |
8/11/2003 |
| Climara (estradiol transdermal system) |
3M Pharmaceuticals |
20375 - S3 |
9/22/1995 |
8/11/2003 |
| Climara (estradiol transdermal system) |
3M Pharmaceuticals |
20375 - S2 |
2/28/1995 |
8/11/2003 |
| Climara (estradiol transdermal system) |
3M Pharmaceuticals |
20375 - S1 |
4/25/1995 |
8/11/2003 |
| Cordarone (amiodarone HCI) I.V. |
Wyeth-Ayerst Laboratories |
20377 - S1 |
10/18/1995 |
8/11/2003 |
| Corzide (Nadolol/Bendroflumethiazide) |
E. R. Squibb and Sons, Inc. |
19647 |
5/25/1983 |
9/13/2002 |
| Crescormon/Somatropin |
Kabi Group |
017992 |
4/6/1979 |
3/5/1999 |
| Crixivan (Indinavir Sulfate) Capsules, 200, 333 & 400 mg |
Merck Research Laboratories |
20685/S41 |
3/13/1996 |
2/20/03 |
| Cyclooort (Amcinonide) Lotion |
Lederle Laboratories |
19729 |
6/13/1988 |
5/25/01 |
| Cylert |
Abbott |
16382/S13
17703/S11 |
4/11/1996 |
6/17/2003 |
| Cylert |
Abbott |
16382/S14
|
9/9/1996 |
6/17/2003 |
| Dextrose Injection USP 5% in Flexible Plastic Container [1.7 MB] |
DHL Laboratories |
019971 |
9/29/1995 |
12/2/1997 |
| Disulfiram Tablets, 250 mg. [5.1 MB] |
Sidmak Laboratories, Inc. |
88482 |
2/8/83 |
4/13/99 |
| Disulfiram Tablets, 500 mg. 2.7 MB] |
Sidmak Laboratories, Inc. |
88483 |
2/8/83 |
4/13/99 |
Dostinex 0.5 mg tablets/Cabergoline 0.5 mg tablets
Part 1 [4.9 MB]
Part 2 [5.5 MB] |
Pharmacia and Upjohn Co. |
020664 |
12/23/1996 |
2/4/1998 |
| Duraclon 0.1mg/ml Injection/Clonidine Injection [7.7 MB] |
Fujisawa |
020615 |
11/2/1996 |
11/4/1996 |
| Dynacirc (Isradipine) Capsules, |
Sandoz Pharmaceuticals Corp. |
19546 |
12/20/1990 |
9/10/2002 |
| Exidine Chlorhexidine Gluconate |
Xttrium |
19125/S28 |
06/06/1996 |
9/11/2003 |
| Fentanyl Oralet (oral transmucosal fentanyl citrate) [649 KB] |
Anesta Corp. |
20195/S-002 |
5/20/96 |
8/2/99 |
| Fragmin/dalteparin sodium Injection [1.5 MB] |
Pharmacia and Upjohn |
020287/S005 |
9/24/1996 |
2/4/1998 |
| Heptolite, Kit for the Preparation of Technetium Tc 99m Disofenin |
Merck |
18467/ S-13 & S-14 |
12/29/1993 |
8/5/2003 |
| Humulin R |
Lilly |
018870/S37 |
1/11/1994 |
6/17/2003 |
Hydrocortisone and Acetic Acid
|
Morton Grove Pharmaceuticals |
040168 |
08/30/1996 |
8/1/2003 |
| Hyzaar (Losartan Potassium and Hydrochlorothiazide) Tablets |
Merck Research Laboratories |
20-387/S003 |
12/1/1995 |
4/30/2002 |
| Imitrex/Sumatriptan succinate [1.3 MB] |
Glaxo-Wellcome |
020080/S005 |
11/23/1996 |
11/20/1997 |
| Invagesic and Invagesic Forte/Aspirin, Caffeine and Orphenadrine Citrate [1 MB] |
Invamed, Inc. |
074817 |
11/11/1996 |
12/2/1997 |
| Iopamidol Injection 41%, 61% 76%/Iopamidol Injection 41%, 61% 76% [1.3 MB] |
Elkins-Sinn |
074629 |
11/6/1996 |
11/7/1997 |
| Isovue/Iopamidol Injection |
Bracco Diagnostics, Inc. |
018735/S033 |
3/14/1996 |
5/7/1998 |
| Klaron Lotion 10%/Sodium Sulfacetamide Lotion 10% [6.8 MB] |
Dermick Laboratories |
019931 |
11/23/1996 |
11/17/1997 |
| Lanoxicaps (Digoxin Solution Capsules) |
Burroughs Wellcome Company |
18118 |
6/26/82 |
8/5/03 |
Levaquin/Levofloxacin
Part 1 [8 MB]
Part 2 [22 MB]
Part 3 [11 MB]
Part 4 [8 MB] |
R.W. Johnson Pharm. |
020634 |
11/20/1996 |
11/26/1997 |
| Levofloxacin Injection [11.4 MB] |
R.W. Johnson Pharm. |
020635 |
12/20/1996 |
12/11/1997 |
| Lupron Depot 3 Month (Leuprolide Acetate for Depot Suspension) [452 KB] |
Tap Holdings, Inc. |
20517/S001 |
12/3/96 |
7/11/00 |
| Lorabid/Loracarbef [0.9 MB] |
Lilly Research Laboratories |
050667/S011
050668/S013 |
11/13/1996 |
11/4/1997 |
Magnevist/Gadopentetate Dimeglumine
Part 1 [4.6 MB]
Part 2 [1.8 MB] |
Berlex Laboratories, Inc. |
019596/S08/S09 |
2/28/1996 |
5/7/1998 |
| Mectizan/Ivermectin [15.7 MB] |
Merck Research Laboratories |
050742 |
11/26/1996 |
11/26/1997 |
| Micro-K LS (Potassium Chloride), |
A.H. Robins Company |
19561 |
8/26/1988 |
9/13/02 |
| Minocycline Hydrochloride Capsules USP, 100 mg, Rx |
Danbury Pharmacal, Inc. |
ANDA 63-065 |
12/30/91 |
7/24/03 |
| Moexipril HCI Tablets, |
Besselaar |
20312 |
4/19/1995 |
9/13/02 |
| MVC-Plus/Aqueous Multi-Vitamin for intravenous infusion [3.5MB] |
Ascot Hospital Pharmaceuticals |
018439 |
7/13/82 |
5/7/1998 |
| Mycrox (metolazone) 1/2 mg Tablets |
Pennwalt Corporation |
19532 |
7/30/87 |
8/5/2003 |
| Naprelan |
Elan Pharmaceutical |
020353 |
03/28/1996 |
8/8/2003 |
| Neomycin and Polymixin 3 Sulfates and Hydrocortisone Otic Suspension, USP |
Carter-Glogau Laboratories, Inc. |
62488 |
11/1/1985 |
7/16/02 |
| Nitro-Dur |
Schering |
020145/s007 |
05/23/1995 |
8/7/2003 |
| Nitro-Dur |
Schering |
020145/s006 |
04/14/1995 |
8/7/2003 |
| Nix Cream Rinse/Permethrin [1.4 MB] |
Warner Lambert Company |
019918/S004 |
11/1/1996 |
12/11/1997 |
| Norvasc (amlodipine besylate) Tablets |
Pfizer Inc. |
19787-S12 |
6/28/1996 |
8/6/2003 |
| Norvasc (amlodipine besylate) Tablets |
Pfizer Inc. |
19787-S11 |
2/7/1996 |
8/6/2003 |
| Norvasc (amlodipine besylate) Tablets |
Pfizer Inc. |
19787-S10 |
2/8/1996 |
8/6/2003 |
| Norvasc (amlodipine besylate) Tablets |
Pfizer Inc. |
19787-S9 |
12/5/1995 |
8/6/2003 |
| Norvasc (amlodipine besylate) Tablets |
Pfizer Inc. |
19787-S8 |
11/2/1995 |
8/6/2003 |
| Norvasc (Amlodipine Besylate) Tablets |
Pfizer Inc. |
19787/S7 |
6/14/1996 |
4/30/2002 |
| Norvasc (amlodipine besylate) Tablets |
Pfizer Inc. |
19787-S6 |
6/19/1995 |
8/6/2003 |
| Norvasc (amlodipine besylate) Tablets |
Pfizer Inc. |
19787-S5 |
2/7/1995 |
8/6/2003 |
| Norvasc (amlodipine besylate) Tablets |
Pfizer Inc. |
19787-S4 |
5/3/1994 |
8/6/2003 |
| Norvasc (amlodipine besylate) Tablets |
Pfizer Inc. |
19787-S3 |
3/3/1994 |
8/6/2003 |
| Norvasc (amlodipine besylate) Tablets |
Pfizer Inc. |
19787-S2 |
1/12/1995 |
8/6/2003 |
| Novantrone/Mixtoxantrone for injection concentrate [16 MB] |
Immunex Corporation |
019297/S014 |
11/13/1996 |
11/20/1997 |
| Nystatin Oral Suspension [1.1 MB] |
UDL Laboratories, Inc. |
64142 |
01/25/1996 |
5/18/2001 |
| Omnipaque/Iohexol Injection [1.2 MB] |
Nycomed Inc. |
018956/S043 |
06/15/1995 |
5/11/1998 |
Omnipaque (iohexol) Injection
|
Sterling Winthrop Inc. |
18956 - S28
|
7/13/93 |
8/5/2003 |
Orgaran injection/Danaproid Sodium injection
Part 1 [7.3 MB]
Part 2 [7.1 MB] |
Organon, Inc. |
020430 |
12/24/1996 |
2/4/1998 |
| Ortho Tri-Cyclen Tablets/Norgestimate and Ethinyl Estradiol [7.6 MB] |
R.W. Johnson Pharmaceutical Research |
020681 |
12/31/1996 |
11/26/1997 |
Oxycontin (oxycodone hydrochloride controlled tablets) 80 mg
Part 1 [1 KB]
Part 2 [2.5 KB] |
Purdue Pharma LP |
20553/S-002 |
12/996 |
8/2/99 |
| Pentasa Capsules 250 MG/Mesalamine [5 MB] |
Marion Merrell Dow |
020049 |
05/10/1993 |
02/18/1998 |
| Percodan (oxycodone HCI, aspirin) |
E.I. Dupont de Nemours & Company |
07337 - S24 |
6/14/1989 |
8/8/2003 |
| Perindopril erbumine [9.4] |
Rhone Poulene Rorer |
020184/S003 |
1/8/1996 |
2/6/1998 |
| Phentermine HCL Capsules 30 mg. [6.3 MB] |
Eon Labs. |
86945 |
1994 |
4/13/99 |
| Phentermine Hydrochloride Capsules, 15 mg. [2 MB] |
Lemmon Company |
87301 |
6/12/81 |
4/13/99 |
| Phentermine Hydrochloride Tablets, 37.5 mg. [1.8 MB] |
Camall Company |
87805 |
12/6/82 |
4/13/99 |
| Phentermine Hydrochloride Tablets, 37.5 mg. [2.1 MB] |
Camall Company |
88596 |
2/16/84 |
4/13/99 |
| Plendil (felodipene) Tablets |
Astra/Merck |
019834/S002 |
9/22/1994 |
8/7/2003 |
| Pralidoxime Chloride for Autoinjection |
Survival Technology |
018986 |
4/26/83 |
6/17/2003 |
| Preparation T (Brand of Testosterone Pellets, USP, 75 mg |
Progynon Associates |
4652/S008 |
8/29/1996 |
8/6/2001 |
| Prilosec Delayed Release capsules/Omeprazole [4.9 MB] |
Astra Merck, Inc. |
019810/S036 |
11/26/1996 |
11/4/1997 |
| Procanbid |
Parke-Davis Pharmaceutical |
020545 |
01/31/1996 |
8/11/2003 |
| Prograf |
Fujisawa |
050708 |
4/8/1994 |
9/10/2003 |
| Prograf |
Fujisawa |
050709 |
4/8/1994 |
9/10/2003 |
| Proscar |
Merck Research Laboratories |
020180 |
08/28/1996 |
8/7/2003 |
| Rhinocort |
Astra USA |
020233/S003 |
02/07/1996 |
8/7/2003 |
| Rocaltrol Capsules [2.1MB] |
Hoffman-La Roche, Inc. |
018044/S018/
S019/S024 |
10/22/1996 |
5/6/1998 |
| Sandostatin/Octreotide Acetate [3.4 MB] |
Sandoz Pharmaceuticals |
019667/S004 |
6/12/1991 |
2/19/1999 |
| Sotradecol (sodium tetradecyl sulfate) |
Elkins-Sinn, Inc. |
05970 - S35 |
9/18/1991 |
8/8/2003 |
| Sotradecol (sodium tetradecyl sulfate) |
Elkins-Sinn, Inc. |
05970 - S30 |
3/31/1987 |
8/8/2003 |
| Sotradecol (sodium tetradecyl sulfate) |
Elkins-Sinn, Inc. |
05970 - S28 |
1/29/1988 |
8/8/2003 |
| Sotradecol (sodium tetradecyl sulfate) |
Elkins-Sinn, Inc. |
05970 - S27 |
8/24/1985 |
8/8/2003 |
| Sotradecol (sodium tetradecyl sulfate) |
Elkins-Sinn, Inc. |
05970 - S22 |
5/3/1977 |
8/8/2003 |
| Sotradecol (sodium tetradecyl sulfate) |
Elkins-Sinn, Inc. |
05970 - S18 |
3/11/1975 |
8/8/2003 |
| Sotradecol (sodium tetradecyl sulfate) 1% and 3% |
Elkins-Sinn, Incorporated |
05970 - S13 |
9/14/1972 |
8/8/2003 |
| Sporanox 100mg capsules/Itraconazole capsules [5.5 MB] |
Janssen Research Foundation |
020694 |
12/6/1996 |
11/4/1997 |
Strotope (strontium Nitrate Sr 85) Injection
appltr.pdf [410 KB]
medr_P1.pdf[2.4 MB]
medr_P2.pdf[1.8 MB]
chemr.pdf[685 KB]
phrmr_admindocs_corres.pdf [3 MB] |
E.R. Squibb and Sons, Inc. |
017024 |
7/9/73 |
7/19/00 |
| TechneScan MDP Kit, |
Merck, Sharp & Dohme |
18035 |
11/28/1978 |
8/14/2002 |
| Temovate |
Glaxo Wellcome |
020340/S003 |
11/15/1996 |
8/8/2003 |
| Temovate |
Glaxo Wellcome |
020337/S001 |
11/15/1996 |
8/8/2003 |
| Temovate (clobetasol propionate) Cream, 0.05% |
Glaxo Wellcome Inc. |
19322 - S15 |
11/15/96 |
8/5/2003 |
| Temovate (clobetasol propionate) Ointment, 0.05% |
Glaxo Wellcome Inc. |
19323 - S16 |
11/15/96 |
8/5/2003 |
| Testosterone Enantnate & Estradiol Valerate Injection, 90/4 mg. per mL. [4.1 MB] |
Carter-Glogau Laboratories, Inc. |
85865 |
5/7/81 |
4/13/99 |
| Tobradex |
Alcon |
050616/S009 |
09/26/1996 |
9/11/03 |
| Tretinoin Topical Solution [494 KB] |
Copley Pharmaceuticals, Inc. |
74873 |
06/19/96 |
5/18/2001 |
VASCOR (bepridil hydrochloride) Tablets
|
The R.W. Johnson Pharmaceutical Research Institute |
19002 - S2 |
5/12/94 |
8/5/2003 |
| Versed/Midazolam Hydrochloride [3.7 MB] |
Hoffman-La Roche Inc. |
018654/S018
S029
S030 |
11/31/1996
3/18/1997 |
11/20/1997 |
| Wellbutrin |
Glaxo Wellcome |
018644/S10,12, 13 |
10/31/96 |
6/17/2003 |
| Xanax Tablets/Alprazolam [2 MB] |
Pharmacia and Upjohn |
018276/S033 |
11/26/1996 |
11/20/1997 |
| Zantac Syrup/Ranitidine HCl [1 MB] |
Glaxo-Wellcome |
019675 |
12/30/1988 |
2/4/1998 |
| Zebeta (Bisoprolol Fumarate) Tablets, 5 & 10 mg |
Lederle Laboratories |
19-982 |
6/11/93 |
8/1/2001 |
| Zebeta (Bisoprolol Fumarate) Tablets |
Lederle Laboratories |
19-982/S1 |
7/31/92 |
8/1/2001 |
| Zebeta (Bisoprolol Fumarate) Tablets & Ziac (HCTZ) Tablets |
Lederle Laboratories |
19-982/S3 & 20-186/S4 |
5/30/95 |
8/1/2001 |
| Zestoretic |
Zeneca Pharmaceuticals |
019888/S020 |
06/13/1995 |
8/8/2003 |
| Zestril (Lisinopril) Tablets |
Stuart Pharmaceuticals |
19-777/S001 |
6/30/1988 |
9/18/01 |
| Zestril (Lisinopril) Tablets |
ICI Pharmaceuticals Group |
19-777/S002 |
9/20/1988 |
8/5/2003 |
| Zestril (Lisinopril) Tablets |
ICI Pharmaceuticals Group |
19-777/S003 |
1/18/1989 |
9/18/01 |
| Zestril (Lisinopril) Tablets |
ICI Pharmaceuticals Group |
19-777/S004 |
4/11/1989 |
9/18/01 |
| Zestril (Lisinopril) Tablets |
ICI Pharmaceuticals Group |
19-777/S006 |
9/5/1989 |
8/5/2003 |
| Zestril (Lisinopril) Tablets |
ICI Pharmaceuticals Group |
19-777/S008 |
11/9/1990 |
8/5/2003 |
| Zestril (Lisinopril) Tablets |
ICI Pharmaceuticals Group |
19-777/S009 |
10/17/1990 |
9/18/01 |
| Zestril (Lisinopril) Tablets |
ICI Pharmaceuticals Group |
19-777/S011 |
7/29/1991 |
8/5/2003 |
| Zestril (Lisinopril) Tablets |
ICI Pharmaceuticals Group |
19-777/S012 |
12/11/1991 |
8/5/2003 |
| Zestril (Lisinopril) Tablets |
ICI Pharmaceuticals Group |
19-777/S013 |
12/12/1992 |
8/5/2003 |
| Zestril (Lisinopril) Tablets |
ICI Pharmaceuticals Group |
19-777/S015 |
11/18/1992 |
8/5/2003 |
| Zestril (Lisinopril) Tablets |
ICI Pharmaceuticals Group |
19-777/S017 |
5/26/1993 |
8/5/2003 |
| Zestril (Lisinopril) Tablet & Zestoretic (Lisinopril & Hydrochlorothiazide) Tablets |
Zeneca Inc. |
19-777/S018 & 19-888/S012 |
3/31/1993 |
9/18/01 |
| Zestril (lisinopril) Tablets |
Zeneca Pharmaceuticals Group |
19777 - S24 |
6/5/1995 |
8/5/2003 |
| Zestril (lisinopril) Tablets |
Zeneca Pharmaceuticals Group |
19777 - S26 |
7/11/1995 |
8/5/2003 |
| Zestril (lisinopril) Tablets |
Zeneca Pharmaceuticals Group |
19777 - S27 |
7/11/1995 |
8/5/2003 |
| Zestril (lisinopril) Tablets |
Zeneca Pharmaceuticals Group |
19777 - S30 |
11/15/1995 |
8/8/2003 |
| Zestril (lisinopril) Tablets |
Zeneca Pharmaceuticals Group |
19777 - S31 |
10/11/1996 |
8/8/2003 |
| Zithromax capsules 250mg/Azithromycin [6.2 MB] |
Pfizer, Inc. |
050670/S008 |
11/22/1996 |
11/4/1997 |
| Zovirax (Acylovir ) Suspension [593 KB] |
Burroughs Wellcome Co. |
NDA 19909/S003 |
2/26/92 |
7/6/00 |
| Zovirax (Acylovir ) Suspension |
Burroughs Wellcome Co. |
NDA 20089/S002 |
2/26/92 |
8/8/2003 |
| Zovirax (acyclovir) Suspension [589 KB] |
Burroughs Wellcome Co. |
18828/S10 |
2/26/1992 |
7/5/2000 |
