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Generic Drug Approval Packages

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.

1997 and Older: Abbreviated New Drug Approvals (Generics)
Product Name-Generic Company Application No. Approved Posted
Acetaminophen and Codeine Phospate Oral Solution 120mg/12mg/5ml [1.9 MB] MOVA Pharmaceutical Corp. 040098 9/20/1996 2/6/1998
Acetaminophen and Codeine Phospate Tablets 300mg/15mg, 300mg/30mg and 300 mg/60 mg [1.9 MB] Duramed Pharmaceuticals, Inc. 040223 11/18/1997 3/27/1998
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate capsules 356.4mg/30mg/16mg [2 MB] Mikart, Inc. 040109 8/26/1997 4/27/1998
Acetaminophen-Codeine Phosphate Purepac Pharmaceutical 086683  05/11/1979 8/4/2003
Acetaminophen-Codeine Phosphate Purepac Pharmaceutical 086681  05/11/1979 8/4/2003
Acetazolamide Tablets USP, 125 mg and 250 mg. [1.8 MB] Taro Pharmaceuticals U.S.A., Inc. 40195 5/28/1997 4/1/1999
Acetic Otic Solution USP, 2 %
Approv
Chemr
Prntlbl		 Morton Grove Pharmaceuticals, Inc. 40166 7/26/1996 8/8/2002
Acyclovir Capsules, 200 mg. [168 KB], Tentatively Approved Roxane Laboratories, Inc. 74570 1996 4/13/97
Acyclovir Capsules 200 mg
Part 1 [5.7 MB]
Part 2 [6.6 MB]		 Zenith Goldline Pharaceuticals, Inc. 074674 4/22/1997 4/1/1998
Acyclovir Capsules, 200 mg. [3.3 MB] Mylan Pharmaceuticals Inc. 74727 4/22/97 4/9/99
Acyclovir Capsules 200mg [1.8 MB] Lek Pharmaceutical and Chemical Co. 074750 4/22/1997 2/6/1998
Acyclovir Capsules, 200 mg. [2.5 MB] Lemmon Company 74828 4/22/97 4/9/99
Acyclovir Capsules, 200 mg. [2.3 MB] Aesgen, Inc. 74833 4/22/97 4/12/99
Acyclovir Capsules 200 mg [13.7 MB] ESI Lederle, Inc. 074872 4/22/1997 1/8/1998
Acyclovir Capsules 200 mg Copley Pharmaceutical 074914 11/26/1997 12/17/1998
Acyclovir Capsules, 200 mg. [2.6 MB] Apothecon, Inc. 74889 10/31/97 4/12/99
Acyclovir Oral Suspension [10 MB] Alpharma 074738 4/23/1997 1/15/1998
Acyclovir Sodium Injection, 500 mg (base)/vial & 1 g (base)/vial. Elan Pharmaceutical 074897
 		 12/10/1997 8/6/2003
Acyclovir Sodium Injection, 500 mg (base)/vial & 1 g (base)/vial. [2.1 MB] Sanofi Pharmaceuticals, Inc. 74663 4/22/97 4/8/99
Acyclovir Sodium [1.6 MB] Abbott Laboratories 074758 4/22/1997 11/7/1997
Acyclovir Sodium for Injection [841 KB] Bedford Laboratories 074596 3/22/1997 1/14/1998
Acyclovir Sodium for Injection 500mg (base)/vial and 1 Gm (base)/vial [1.2 MB] Gensia Laboratories, Ltd. 074969 8/26/1997 3/30/1998
Acycovir Tablets 400 mg and 800 mg [12 MB] Lek Pharmaceutical and Chemical Co. 074658 4/22/1997 1/14/1998
Acyclovir Tablets, 400 mg & 800 mg. [2.9 MB] ESI Lederle, Inc. 74834 4/24/97 4/12/99
Acyclovir Tablets, 400 mg & 800 mg. [2.3 MB] Zenith Goldline Pharmaceuticals, Inc. 74836 4/22/97 4/12/99
Acyclovir Tablets 400 mg & 800 mg [3.6 MB] Purepac Pharmaceutical Co. 74870 6/5/97 4/12/99
Acycovir Tablets 400 mg and 800 mg [7 MB] Applied Analytical Industries, Inc. 074946 11/19/1997 3/30/1998
Adriamycin PFS (Doxorubicin Hydrochloride) Injection,  Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002
Albuterol Inhalation Aerolsol, 90 mcg/Actuation. [11.6 MB] Alpharma, U.S. Pharmaceuticals Division 73045 8/19/1997 4/1/1999
Alprazolam Tablets [7.9 MB] Royce Laboratories, Inc. 074479 1/21/1997 2/6/1998
Amitriptyline HCl Tablets 10mg [1 MB] Danbury Pharmacal, Inc. 088620 3/2/1984 2/6/1998
Amitriptyline HCl Tablets 10mg, 25mg, 50mg, 75mg, 100mg, and 150mg
Part 1 [2.8 MB]
Part 2 [8.5 MB] 		Vintage Pharmaceuticals, Inc. 040218 9/11/1997 4/27/1998
Amitriptyline HCl Tablets 25mg [966 KB] Danbury Pharmacal, Inc. 088621 3/2/1984 2/6/1998
Amitriptyline HCl Tablets 50mg [983 KB] Danbury Pharmacal, Inc. 088622 3/2/1984 2/6/1998
Amitriptyline HCl Tablets 75mg [826 KB] Danbury Pharmacal, Inc. 088633 3/2/1984 2/6/1998
Amitriptyline HCl Tablets 100mg [843 KB] Danbury Pharmacal, Inc. 088634 3/2/1984 2/6/1998
Amitriptyline HCl Tablets 150mg [841 KB] Danbury Pharmacal, Inc. 088635 3/2/1984 3/24/1998
Amoxicillin Chewable Tablets [1.8 MB] Novopharm, Ltd. 064031 12/19/1996 11/17/1997
Adriamycin
 		 Adria Laboratories 063165/s3,s5,s6 07/09/1993 8/4/2003
Atenolol and Chlorthalidone Tablets 50mg/25mg and 100mg/25 mg
Approval Letter/Final Printed Labeling
Chemistry Review
Bioequivalence Review Part 1 [17 MB]
Bioequivalence Review Part 2 [6 MB]
Bioequivalence Review Part 3 [4 MB]		 Sidmark Laboratories, Inc. 074107 9/24/1997 3/30/1998
Atracurium Besylate Injection 10mg/ml, 5ml and 10ml Multiple Dose Vials [1 MB] Gensia Laboratories, Ltd. 074784 6/11/1997 3/30/1998
Atracurium Besylate Injection 10mg/ml in a 5ml Abboject Syringe [946 KB] Abbot Laboratories 074639 3/25/1997 4/27/1998
Bacitracin 50,000 units/vial [2 MB] Pharma-Tex, Inc. 064153 5/9/1997 3/30/1998
Benzedrine (Amphetamine Sulfate) Tablets SmithKline & French Laboratories 83-900 2/26/1976 12/17/2001
Benztropine Mesylate Tablets [10.9 MB] Rosemont Pharmaceutical Corp. 040103 12/12/1996 12/11/1997
Betamethasone Dipropionate Cream USP, 0.05% (base). [3.7 MB] Clay-Park Labs, Inc. 74579 11/26/97 4/7/99
Bleomycin Sulfate
 		 Pharmacia 064084 06/03/1996 8/4/2003
Brompheniramine Chromalloy Pharmaceuticals 085888 04/26/1978 8/6/2003
Bumetanide Injection USP, 0.25 mg/mL. [1.1 MB] Abbott Laboratories 74160 10/30/97 4/7/99
Bumetanide Injection 0.25 mg/ml [733 KB] Gensia Laboratories 074613 11/18/1997 3/19/1998
Bumetanide Tablets [8.8 MB] Eon Labs Manufacturing, Inc. 074700 11/21/1996 2/6/1998
Butorphanol Tartrate 1 mg/ml (1 ml/ml single dose vials) and 2 mg/ml (1 ml and 2 ml single dose vials) [1.5 MB] Abbot Laboratories 074626 1/23/1997 3/30/1998
Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, & 100 mg. [2.1 MB] Wockhardt Limited 74532 3/28/97 4/7/99
Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg & 100 mg. [2.9 MB] Stason Industrial Corporation 74677 3/30/97 4/8/99
Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, & 100 mg. [1.9 MB] Aegis Pharmaceuticals, Inc. 74748 5/23/97 4/9/99
Captopril & Hydrochlorothiazide Tablets USP, 25mg/15mg, 50mg/15mg, 25mg/25mg, & 50mg/25mg. [167 KB] Tenetively Approved 7/21/97 Lemmon Company 74827 7/21/97 4/9/99
Captopril & Hydrochlorothiazide Tablets USP, 50 mg/25 mg. [1.4 KB] Danbury Pharmacal, Inc. 74832 12/29/97 4/12/99
Carbamazepine Tablets 200mg [3.4 MB] Taro Pharmaceuticals, USA, Inc. 074649 10/3/1996 2/6/1998
Carisprodol Tablets USP [503 KB] Royce Laboratories, Inc. 040152 12/3/1996 12/1/1997
Carisprodol Tablets 350mg [910 KB] Vintage Pharmaceuticals, Inc. 040245 9/8/1997 4/27/1998
Carisoprodol and Aspirin Tablets 200mg/325mg [1.5 MB] Amide Pharmaceutical, Inc. 040252 12/10/1997 3/27/1998
Carisoprodol Tablets USP, 350 mg. [1 MB] Amide Pharmaceutical, Inc. 40188 3/7/1997 4/1/1999
Cefaclor Capsules USP, 250 mg (base) and 500 mg (base). [4.1 MB] Ranbaxy Laboratories Limited 64156 8/28/1997 4/1/1999
Cefaclor Capsules USP, 250 mg (base) and 500 mg (base), 
Approv
Chemr
Prntlbl		 Biocraft Laboratories, Inc. 64081 9/16/1996 8/8/2002
Cefaclor Oral Suspension, USP, 375 mg/5mL, 250mg/5mL, 187mg/5mL,  & 125/5mL [2.6 MB] Ranbaxy Pharmaceuticals Inc. 64155, 64164, 64165, 64166 10/2/1997 4/1/1999
Cefuroxime Sodium 750 mg (base)/vial and 1.5 Gm (base)/vial, [5 MB] G.C. Hanford Manufacturing Co. 064125 5/30/1997 3/30/1998
Cefuroxime Sodium 7.5 Gm (base)/vial, Pharmacy Bulk Package [1.3 MB] G.C. Hanford Manufacturing Co. 064124 5/30/1997 3/30/1998
Cimetidine Hydrochloride Injection, 300 mg (base)/2 mL. [4 MB] Gensia Laboratories, Ltd. 74252 11/26/97 4/7/99
Cimetidine HCl Injection 300mg (base)/2ml, Carpuject [1.5 MB] Sanofi Pharmaceuticals, Inc. 074296 3/28/1997 4/27/1998
Cimetidine HCl Injection 300mg (base)/2ml, 2ml and 8ml multiple dose vials  [1.7 MB] Sanofi Pharmaceuticals 074412 3/28/1997 4/27/1998
Cimetidine Tablets USP, 800 mg. [2.1 MB] Sidmak Laboratories, Inc. 74566 2/27/97 4/7/99
Cimetidine Tablets USP, 200 mg, 300 mg & 400 mg. [2.4 MB] Sidmak Laboratories, Inc. 74568 2/27/97 4/7/99
Cimetidine HCl Oral Solution 300 mg/5 ml (base) [1 MB] Hi-Tech Pharmacal Co., Inc. 074664 10/28/1997 3/30/1998
Cimetidine HCl Oral Solution 300 mg/5 ml (base) [1.2 MB] Morton Grove Pharmaceuticals, Inc. 074757 10/17/1997 3/30/1998
Cimetidine HCl Oral Solution 300 mg/5 ml (base) [1.6 MB] Pharmaceutical Associates, Inc. 074553 1/27/1997 3/30/1998
Clindets [Clindamycin Phosphate Topical Swab (Pledgets)], 1% (base). [1.5 MB] Stiefel Laboratories, Inc. 64136 9/30/96 4/13/99
Clomipramine Hydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997
Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg. [5 MB] Novopharma N.C. Inc. 74849 4/4/97 4/12/99
Clobetasol Propionate Cream/Cormax 0.05% [2.8 MB] Healthpoint, Ltd. 074220 5/16/1997 3/30/1998
Clomipramine HCL Capsules 25 mg, 50 mg, & 75 mg. [3.8 MB] Lemmon Company 74958 8/26/97 4/13/99
Clonazepam Tablets 0.5mg, 1mg, and 2mg [4.1 MB] Invamed, Inc. 074925 9/30/1997 3/30/1998
Clonazepam Tablets USP, 0.5 mg, 1 mg & 2 mg. [1.8 MB] Lipha Pharmaceuticals, Inc. 74940 10/30/97 4/13/99
Clonazepam Tablets USP, 0.5 mg, 1 mg & 2 mg. [2 MB] Eon Labs Manufacturing, Inc. 74979 8/29/97 4/13/99
Clozapine Tablets 25 mg & 100 mg. [1.6 MB] Zenith Goldline Pharmaceuticals, Inc. 74949 11/26/97 4/13/99
Col-Probenecid Danbury Pharmacal 084279 11/23/1976 8/6/2003
Cyanocobalamin Elkins Sinn 080515 10/20/1971 8/6/2003
Cyclosporine, USP (non-sterile bulk). [1.8 MB] Fujian Institute of Microbiology 64104 7/2/1997 4/1/1999
Cyclospirine (non sterile bulk) [554 KB] AAC Consulting Group, Inc. 064179 7/2/1997 4/27/1998
Cyclosporine (non sterile bulk) [197 KB] Abbott Laboratories 064208 10/31/1997 4/27/1998
Danazol Capsules USP, 200 mg Barr Laboratories 74582 8/9/1996 8/8/2002
Delcobese Capsules Delco Chemical Company 83594 10/24/1975 1/24/02
Desipramine Hydrochloride Tablets USP, 100 mg. [4.5 MB] Sidmak Laboratories, Inc. 71803 5/29/1997 4/1/1999
Desipramine Hydrochloride Tablets USP, 150 mg. [1.3 MB] Sidmak Laboratories, Inc. 71804 5/29/1997 4/1/1999
Desmopressin Acetate Injection 4mg/ml [801 KB] Gensia Laboratories, Ltd. 074888 10/15/1997 3/30/1998
Diclofenac Sodium Delayed-release Tablets USP, 25, 50, & 75 mg. [6 MB] Copley Pharmaceutical, Inc. 74459 6/24/97 4/7/99
Dicloxacillin Sodium Capsules 250 mg & 500 mg. [1 MB] Ayerst Laboratories, Inc. 62238 1/31/80 4/13/99
Dicyclomine Hydrochloride capsules 10 mg [2.5 MB] West-Ward Pharmaceutical Corp. 040204 2/28/1997 4/27/1998
Diflunisal Tablets USP, 50 mg & 500 mg. Danbury Pharmacal, Inc. 74400 7/17/97 4/7/97
Diflunisal Tablets USP, 250 mg & 500 mg. Purepac Pharmaceutical Co. 74285 5/7/1996 8/8/2002
Diltiazem HCl Injection 5mg/ml [1 MB] Gensia Laboratories, Ltd. 074894 8/26/1997 3/30/1998
Diltiazem HCl Extened-Release Capsule 60mg, 90mg, and 120 mg [4.7 MB] Mylan Pharmaceuticals, Inc. 074910 5/2/1997 4/1/1998
Diltiazem HCl Extended-Release Capsule 120 mg, 180 mg, 240 mg [12 MB] Andrx Pharmaceuticals 074852 10/10/1997 3/19/1998
Diphenhydramine Hydrochloride Capsules USP, 25 mg. [2.6 MB] Mutual Pharmaceutical Co., Inc. 89488 1/2/87 4/13/99
Diphenhydramine Hydrochloride Capsules USP, 50 mg. [2.6 MB] Mutual Pharmaceutical Co., Inc. 89489 1/2/87 4/13/99
Diphenoxylate HCI & Atropine Sulfate Tablets Generic Pharmaceutical Corp. 85035 7/5/77 1/17/02
Dipyridamole Injection, 5 mg/mL. [2.2 MB] Abbott Laboratories 74601 12/19/97 4/7/99
Dobutamine HCl injection 12.5 mg/ml [1.1 MB] Elkins-Sinn 074381 9/26/1996 2/6/1998
Dobutamine HCl Injection 1250 mg/100ml [545 KB] Abbott Laboratories 074634 9/27/1996 2/6/1998
Doxylamine Succinate Tablets USP, 25 mg. [597 KB] L. Perrigo Company 40167 9/15/96 4/13/99
Epifoam/Hydrocortisone Acetate 1% and Pramoxine Hydrochloride 1% [1.8 MB] Schwartz Pharma 086457 10/1980 12/1/1997
Erythromycin Pledgets 2% (jar) [940 KB] Stiefel Laboratories 064126 7/3/1996 2/6/1998
Erythromycin Pledgets 2% (individual) [1.2 MB] Stiefel Laboratories 064128 7/3/1996 2/6/1998
Erythromycin Topical Solution 2% [713 KB] Stiefel Laboratories 064127 2/14/1997 4/27/1998
Erythromycin Topical Gel USP, 2% [975 KB] Altana Inc. 64184 9/30/1997 4/1/1999
Estazolam Tablets, 1 mg & 2 mg. [1.8 MB] Royce Laboratories, Inc. 74818 8/19/97 4/9/99
Estazolam Tablets, 1 mg & 2 mg. [2.2 MB] Zenigh Goldline Pharmaceuticals, Inc. 74826 7/3/97 4/9/99
Estradiol Tablets 0.5mg, 1mg, 1.5mg, and 2mg  [3.5 MB] Duramed Pharmaceuticals, Inc. 040212 12/29/1997 4/27/1998
Estradiol Tablets USP, 0.5 mg, 1 mg and 2 mg. [2.8 MB] Barr Laboratories, Inc. 40197 10/22/1997 4/1/1999
Estrone Chromalloy Pharmaceuticals 085239 02/21/1979 8/6/2003
Estropipate Tablets [1.8 MB] Barr Laboratories 040135 11/27/1996 12/1/1997
Etodolac Tablets [11 MB] Geneva Pharmaceuticals 074839 7/11/1997 1/8/1998
Etodolac Capsules, 200 mg & 300 mg. [4.8 MB] Geneva Pharmaceuticals, Inc. 74840 8/29/97 4/12/99
Etodolac Capsules, 200 mg & 300 mg. [3.1 MB] Endo Laboratories, L.L.C. 74842 7/17/97 4/12/99
Etodolac Capsules, 200 mg & 300 mg. [2.8 MB] Mylan Pharmaceuticals Inc. 74932 5/16/97 4/13/99
Etodolac Tablets, 400 mg. [971 KB] Purepac Pharmaceutical Co. 74819 6/12/97 4/13/99
Etodolac Tablets, 400 mg. [2.7 MB] Invamed Inc. 74846 2/28/97 4/12/99
Etodolac Tablets, 400 mg. [2 MB] Zenith Goldline Pharmaceuticals, Inc. 74883 2/28/97 4/12/99
Etodolac Tablets 400 mg. [2.6 MB] Applied Analytical Laboratories, Inc. 74927 10/30/97 4/13/99
Etomidate Injectable 2mg/ml 10 and 20ml vials [0.6 MB] Bedford Laboratories 074593 10/11/1996 11/4/1997
Etoposide Injection 20mg/ml, 5ml multiple dose vials [935 KB] Guidelines, Inc. 074813 7/9/1997 3/30/1998
Fluocinonide Topical Solution [569 KB] Taro Pharmaceuticals 074799 12/31/1996 12/3/1997
Fluphenazine Decanoate Injection 25mg/ml [1.2 MB] Gensia Laboratories, Inc. 074795 9/10/1996 2/6/1998
Fluphenazine HCl Oral Solution Concentrate 5mg/ml [1.7 MB] Pharmaceutical Associates, Inc. 074725 9/16/1996 2/6/1998
Flurbiprofen Tablets, USP, 100 mg. [2.8 MB] Warner Chilcott, Inc. 74560 3/16/97 4/7/99
Flurbiprofen Tablets USP, 50 mg & 100 mg. [2.5 MB] Sidmak Laboratories, Inc. 74647 4/1/97 4/7/99
Glipizide Tablets 5mg and 10 mg [1.9 MB] Duramed Pharmaceuticals 074550 9/11/1997 3/19/1998
Glipizide Tablets USP, 5 mg and 10 mg Sidmark 074619 4/4/1997 12/17/1998
Glyburide Tabs (micronized), 1.5 mg, 3 mg, 4.5 mg, & 6 mg. MOVA Pharmaceutical Corporation 74591 2/11/97 4/7/99
Glyburide [1.3 MB] Mylan Pharmaceuticals, Inc 074792 12/19/1996 11/7/1997
Grifulvin V Ortho Pharmaceutical 062483 01/26/1984 8/3/2003
Grifulvin V Ortho Pharmaceutical 062483 S001 04/12/1990 8/3/2003
Grifulvin V Ortho Pharmaceutical 062483 S002 08/29/1994 8/3/2003
Grifulvin V Ortho Pharmaceutical 062483 S003 03/3/1991 8/3/2003
Grifulvin V Ortho Pharmaceutical 062483 S004 03/4/1992 8/3/2003
Grifulvin V Ortho Pharmaceutical 062483 S005 03/17/1994 8/3/2003
Grifulvin V Ortho Pharmaceutical 062483 S006 11/6/1995 8/3/2003
Grifulvin V Ortho Pharmaceutical 062483 S007 03/21/1997 8/3/2003
Grifulvin V Ortho Pharmaceutical 062483 S008 03/22/1990 8/3/2003
Grifulvin V Ortho Pharmaceutical 062483 S009 09/17/1991 8/3/2003
Grifulvin V Ortho Pharmaceutical 062483 S10 07/14/1992 8/3/2003
Grifulvin V Ortho Pharmaceutical 062483 S11 04/13/1993 8/3/2003
Grifulvin V Ortho Pharmaceutical 062483 S12 11/22/1995 8/3/2003
Guanfacine Tablets [5.7 MB] Amide Pharmaceutical, Inc. 074673 2/28/1997 3/20/1998
Guanfacine Tablets USP, 1 mg (base) & 2 mg (base). [3.3 MB] Royce Laboratories 74762 6/24/97 4/9/99
Guanfacine Hydrochloride Tablets USP, 1 mg & 2 mg (base) [2.8 MB] Mylan Pharmaceuticals, Inc. 74796 1/27/97 4/9/99
Heparin Sodium injection  10,000u/ml [1.3 MB] Sanofi Withrop, Inc. 040095 7/26/1996 2/6/1998
Hydralazine Hydrochloride Injection USP, 20 mg/mL. [610 KB] Luitpold Pharmaceuticals, Inc. 40136 6/30/1997 4/1/1999
Hydrochlorothiazide Barr Laboratories 083972 10/03/1974 8/6/2003
Hydrochlorothiazide Camall 083965 03/21/1977 8/6/2003
Hydrochlorothiazide Danbury Pharmacal 083232 01/24/1975 8/6/2003
Hydrochlorothiazide Richlyn Laboratories 083607 08/19/1977 8/6/2003
Hydrocodone Bitartrate and Acetaminophen Tablets 5mg/325mg [1.2 MB] UCB Pharma, Inc. 040099 6/25/1997 3/27/1998
Hydrocodone Bitartrate and Acetaminophen Tablets 5mg/500 mg and 7.5 mg/750 mg [1.2 MB] Halsey Drug Company, Inc. 040236 9/25/1997 3/27/1998
Hydrocodone Bitartrate and Acetaminophen 7.5 mg/650mg   [581 KB] UCB Pharma, Inc. 040134 12/21/1996 12/3/1997
Hydrocodone Bitartrate and Acetaminophen 10 mg/325 mg and 10 mg/500 mg  [706 KB] Watson Laboratories, Inc. 040148 2/14/1997 3/23/1998
Hydrocodone Bitratrate and Acetaminophen tablets 10mg/500mg [2 MB] Peachtree Pharmaceuticals 040210 8/13/1997 4/27/1998
Hydrocodone Bitartrate and Acetaminophen Tablets 10mg/650mg and 7.5mg/650mg [2 MB] Halsey Drug Company, Inc. 040240 11/26/1997 4/27/1998
Hydrocodone Bitartrate and Acetaminophen Tablets 7.5mg/650mg [1.2 MB] Vintage Pharmaceuticals, Inc. 40155 4/14/1997 4/1/1999
Hydrocortisone acetate powder [418 KB] Pharm-Tek, Inc. 085981 5/9/1987 12/1/1997
Hydrocortisone & Acetic Acid Otic Solution USP, 
Approv
Chemr
Prntlbl		 Morton Grove Pharmaceuticals, Inc. 40168 8/30/1996 8/8/2002
Iopamidol Injection USP 61% single dose vial [979 KB] Abbott Laboratories 074368 4/30/1997 4/15/1998
Iopamidol Injection USP 61%, 76% [979 KB] Faulding Hospital Products, Inc. 074734 12/10/1996 12/1/1997
Iopamidol Abbott Laboratories 074898 12/30/1997 8/6/2003
Isoniazid Tablets 100mg and 300mg [1.9 MB] Mikart, Inc. 040090 6/26/1997 3/27/1998
Ketamine HCl Injection 50mg/ml and 100 mg/ml [1.5 MB] Sanofi Winthrop, Inc. 074549 6/27/1996 2/6/1998
Ketoprofen Capsules [2.0 MB] Mylan Pharmaceuticals, Inc. 074035 12/31/1996 11/17/1997
Ketoprofen Extended-release Capsules, 200 mg. [1.8 MB] Elan Pharmaceutical Research Corporation 74879 12/10/97 4/12/99
Ketorolac Tromethamine Tablets USP, 10 mg. [3 MB] Lemmon Company 74754 5/16/97 4/9/99
Ketorolac Tromethamine Tablets USP, 10 mg. [2.2 MB] Mylan Pharmaceuticals, Inc. 74761 5/16/97 4/9/99
Ketorolac Tromethamine Tablets USP, 10 mg. [2 MB] Roxane Laboratories, Inc. 74790 6/26/97 4/9/99
Lactulose Solution 10g/15ml [397 KB] Morton Grove Pharmaceuticals, Inc. 074602 11/14/1996 12/1/1997
Lactulose Solution 10g/15ml [1.7 MB] Pharmaceuticals Associates, Inc. 074623 7/30/1996 2/6/1998
Leucovorin Calcium Injection 10mg/ml 10ml and 25ml single dose vials [1.3 MB] Abbott Laboratories 040147 6/25/1997 3/27/1998
Klor-Con M20 (Potassium Chloride Extended-release Tablets USP, 20 mEq) [229 KB] Tenetively Approved 3/6/97 Upsher-Smith Laboratories, Inc. 74726 3/6/97 4/9/99
Leucovorin Calcium Tablets, USP, 5 mg & 25 mg (base) [1.6 MB] Pharmachemie USA, Inc. 73099/73101 3/28/99 4/7/99
Leucovorin Calcium Tablets USP, 5 mg (base) & 25 mg (base). [3 MB] Par Pharmaceutical, Inc. 74544 8/28/97 4/7/99
Leucovorin Calcium for Injection 50 mg [1.2 MB] Pharmachemie B.V. 089628 4/17/1997 3/19/1998
Leucovorin Calcium for Injection 100 mg [918 KB] Pharmachemie B.V. 089915 4/17/1997 3/27/1998
Leucovorin Calcium for Injection 350 mg [918 KB] Gensia Laboratories 040174 6/12/1997 3/27/1998
Loperamide HCl Oral Solution 1 mg/5 ml Morton Grove Pharmaceuticals, Inc. 074730 8/28/1997 3/30/1998
Loperamide Hydrochloride Oral Solution, 1 mg/5 mL. [1 MB] Duramed Pharmaceuticals, Inc. 74991 12/29/97 4/13/99
Lorazepam Oral Solution, 0.5 mg/5 mL. [3.5 MB] Roxane Laboratories, Inc. 74-648 3/18/97 4/8/99
Meperidine Hydrochloride Tablets 50 mg and 100 mg [1.4 MB] Roxane Laboratories, Inc. 40110 3/12/1997 4/1/1999
Meperidine Hydrochloride Injection 10mg/ml 60 ml syringe [800 KB] Mallinckrodt Chemical, Inc. 040163 5/12/1997 3/27/1998
Meperidine Hydrochloride Tablets 50 mg and 100 mg [1.2 MB] Royce Laboratories, Inc. 040186 6/30/1997 3/19/1998
Methzolamide Tablets USP, 25 mg and 50 mg. [4.2 MB] Applied Analytical Industries, Inc. 40011 7/17/1997 4/1/1999
Metoclopramide Oral Solution 5 mg (base)/5 ml [3.1 MB] JVL Corp. 074703 10/31/1997 3/30/1998
Methylprednisolone Tablets 4mg [9 MB] Invamed, Inc. 040194 10/31/1997 3/27/1998
Methylprednisolone Tablets 4mg [4.8 MB] Chelsea Laboratories, Inc. 040232 10/16/1997 4/27/1998
Methylprednisolone Tablets 4mg and 8mg [4.5 MB] Trigen Laboratories, Inc. 040189 10/31/1997 4/27/1998
Metoprolol Tartate [1.2 MB] Caraco Pharmaceuticals Ltd 074644 12/10/1996 12/3/1997
Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, & 250 mg. [2.6 MB] Watson Laboratories, Inc. 74711 2/27/97 4/9/99
Miconazole Nitrate Vaginal Cream 2% [1.8 MB] Taro Pharmaceuticals, Inc. 074444 1/13/1997 11/17/1997
Minocycline Hydrochloride Capsules USP, 50 mg. [4.6 MB] Warner Chilcott, Inc. 63066/S011, S010, S009, S008, S007, & S006 5/12/1997 4/1/1999
Minocycline Hydrochloride Capsules

 		 Danbury Pharmacal, Inc. ANDA 63-065 12/30/91 8/4/2003
Nadolol Tablets USP 20 mg & 40 mg. [5.6 MB] Zenith Goldline Pharmaceuticals, Inc. 74229 8/30/96 4/13/99
Nafcillin Sodium Injection, USP, 500 mg, 1g, 1.5g, 2g, & 4g. [1 MB] Marsam Pharmaceuticals, Inc. 62844 10/26/88 4/13/99
Naproxen Tablets 250 mg, 375 mg, & 500 mg. [4.6 MB] Danbury Pharmacal, Inc. 74163 2/10/95 4/13/99
Naproxen Tablets 250mg, 375 mg, and 500 mg [4 MB] Sidmark Laboratories 074182 6/27/1996 2/6/1998
Naproxen Sodium Tablets 275mg and 550mg
Part 1 [5 MB]
Part 2 [4 MB]		 Sidmark Laboratories 074242 6/20/1996 3/30/1998
Naproxen Sodium Tablets USP, 220 mg (eg. 200 mg base) [2.1 MB] L. Perrigo Company 74661 1/13/97 4/8/99
Nicardipine HCL Capsules 20 mg & 30 mg. [3.6 MB] Zenith Goldline Pharmaceuticals 74439 12/10/96 4/13/99
Nicotine Transdermal System USP, 7 mg/day Sano Corporation 074645 10/20/1997 12/17/1998
Nicotine Transdermal System USP, 14 mg/day Sano Corporation 074611 10/20/1997 12/17/1998
Nicotine Transdermal System USP, 21 mg/day Sano Corporation 074612 10/20/1997 12/17/1998
Nitrofuran Capsules (Macrocrystals) USP, 50 mg & 100 mg. [1.8 MB] Mylan Pharmaceuticals, Inc. 74967 7/9/97 4/13/99
Nortriptyline HCl Capsule 10mg, 25mg, 50mg, and 75mg
Part 1 [610 K]
Part 2 [4.5 MB]		 Invamed, Inc. 074835 6/30/1997 4/1/1998
Nystatin Oral Suspension USP,  Lachman Consultant Services, Inc. 64142 9/18/1996 8/8/2002
Orasone Rowell Laboratories 083009  01/29/1974 8/6/2003
Orphenadrine Citrate, Aspirin and Caffeine tablets [1.3 MB] Eon Labs Manufacturing, Inc. 074654 12/31/1996 11/17/1997
Oxybutynin Chloride Syrup USP, 5 mg/5 ml Morton Grove Pharmaceuticals 074868 2/12/1997 12/17/1998
Oxybutynin Chloride Tablets USP, 5mg [2.2 MB] Rosemont Pharmaceutical Corporation 74625 6/31/96 4/13/99
Oxybutynin Chloride Tablets 5mg Vintage Pharmaceuticals, Inc. 075079 10/31/1997 3/30/1998
Oxycodone and Acetaminophen capsules 5mg/325 mg [1.1 MB] Royce Laboratories. 040171 10/30/1997 4/27/1998
Oxycodone and Acetaminophen tablets 5mg/325 mg [1.5 MB] Vintage Pharmaceuticals, Inc. 040105 7/30/1996 2/6/1998
Oxycodone and Acetaminophen capsules 5mg/500 mg [1.5 MB] Royce Laboratories. 040234 10/30/1997 4/15/1998
Oxycodone and Acetaminophen capsules 5mg/500 mg [1.5 MB] Vintage Pharmaceuticals, Inc. 040106 7/30/1996 2/6/1998
Paromomycin Sulfate Capsule 250mg [2.5 MB] Caraco Pharmaceutical Laboratories, Ltd. 064171 6/30/1997 4/27/1998
Pentazocine and Naloxone tablets [10 MB] Royce Laboratories, Inc. 074736 1/17/1997 1/8/1998
Pentoxifylline Extended-release Tablets, 400 mg. [7.2 MB] Mylan Pharmaceuticals, Inc. 74425 7/8/97 4/7/99
Pentoxifylline Extended-release Tablets, 400 mg. [7 MB] ESI Lederle, Inc. 74877 7/8/97 4/7/99
Pentoxifylline Extended-release Tablets, 400 mg. [3.5 MB] Purepac Pharmaceutical Co. 74878 7/9/97 4/12/99
Periogard Colgate 073695 01/14/1994 8/27/2003
Phentermine HCl Capsules 30mg [995 KB] Amide Pharmaceutical, Inc. 040227 6/18/1997 4/27/1998
Pindolol Tablets USP, 5 mg & 10 mg. [1.6 MB] Lemmon Company 74123 4/17/97 4/7/99
Piroxicam Capsules USP, 10 mg & 20 mg. [2.2 MB] Aegis Pharmaceuticals, Inc. 74808 7/8/97 4/9/99
Prednicen-M The Central Pharmacal 084655 12/09/1975 8/6/2003
Prelone Muro Pharmaceutical 089081 02/04/1986 8/6/2003
Proben-C Chelsea Laboratories 085552 09/15/1977 8/6/2003
Probenecid
 		 Lederle Laboratories 086954 09/06/1979 8/4/2003
Probenecid Danbury Pharmacal 083221 04/07/1975 8/6/2003
Probenecid Premo Pharmaceutical 086130 03/18/1980 8/6/2003
Probenecid and Colchicine Beecham Laboratories 084321 03/11/1976 8/6/2003
Primsol Solution (Trimethoprim Hydrochloride Oral Solution) 25 mg(base)/5 mL. [10 MB] Ascent Pediatrics, Inc. 74374/S-001, S-002 6/17/97 4/7/99
Procainamide HCl Extended Release Tablets 1000 mg [2.4 MB] Copley Pharmaceuticals 040111 12/13/1996 12/1/1997
Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg (base). [2.4 MB] Duramed Pharmaceuticals, Inc. 40207 5/1/1997 4/1/1999
Promethacon Alcon Laboratories 084902 10/05/1981 8/6/2003
Promethazine Hydrochloride & Dextromethorphan Hydrobromide Syrup,  Hi-Tech Pharmacal Co. Inc. 40027 7/31/1996 8/8/2002
Promethgan 50 mg/Promethazine Hydrochloride [1.3 MB] G & W Laboratories 087165 supplements 1991 12/1/1997
Propoxyphene HCl and Acetaminophen 65mg-650 mg Tablets [831 KB] Royce Laboratories 040139 12/16/1996 12/1/1997
Propoxyphene Napsylate & Acetaminophen Tablets USP, 100 mg/650 mg. [2.6 MB] Vintage Pharmaceuticals, Inc. 74843 2/12/97 4/12/99
Ranitidine Tablets USP, 150 mg & 300 mg [1.6 MB] Lipha Pharmaceuticals, Inc. 74023 8/22/97 4/7/99
Ranitidine Tablets [3.8 MB] Geneva Pharmaceuticals, Inc. 074467 8/29/1997 3/20/1998
Ranitidine Capsules, 150 mg & 300 mg [2.9 MB] Geneva Pharmaceuticals, Inc. 74655 10/30/97 4/8/99
Ranitidine Oral Solution USP, 15 mg/mL. [325 KB] Tenetively Approved 5/18/97 UDL Laboratories, Inc. 74794 5/18/97 4/9/99
Ranitidine Tablets USP, 150 mg & 300 mg. [3 MB] Chelsea Laboratories, Inc. 74864 10/20/97 4/12/99
Rifampin Capsules 300mg
Approval Letter
Final Printed Labeling
Chemistry Review
Bioequivalence Review Part 1 [3 MB]
Bioequivalence Review Part 2 [17 MB]
Bioequivalence Review Part 3 [5 MB]		 Eon Labs Manufacturing, Inc. 064150 5/28/1997 3/30/1998
Selegiline Hydrochloride Tablets 5mg [4.2 MB] Granutec Inc./Novopharm Ltd. 074537 8/26/1996 2/6/1998
Selegiline Hydrochloride Tablets 5mg [5.8 MB] Endo Laboratories, Inc. 074565 8/2/1996 2/6/1998
Selegiline Hydrochloride Tablets 5mg [4.1 MB] Lederle Laboratories 074641 8/2/1996 2/6/1998
Selegiline Hydrochloride Tablets 5mg [2.9 MB] Apothecon, Inc. 074672 8/1/1997 2/6/1998
Selegiline Hydrochloride Tablets 5mg [3.2 MB] Lemmon Company 074744 1/27/1997 2/6/1998
Sterile Bleomycin Sulfate USP, 15 & 30 Unit/vial Pharmacia Inc. 64084 6/3/1996 8/8/2002
Sufentanil Citrate Injection 50mg/ml [1.4 MB] Abbott Laboratories 074534 12/11/1996 2/6/1998
Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL. [2.8 MB] Hi-Tech Pharmacal Co., Inc. 74650 12/29/97 4/8/99
Sulster (Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution 10%/ eq. 0.23% phosphate) Akorn, Inc. 74511 7/30/1996 8/8/2002
Terazosin Hydrochloride Tablets, 1 mg (base), 2 mg (base), 5 mg (base) & 10 mg (base) [177 KB] Tenetively Approved 7/16/97 Lemmon Company 74651 7/16/97 4/8/99
Terfenadine Tablets 60 mg [2.1 MB] Baker Norton Pharmaceuticals, Inc. 074475 1/3/1997 3/23/1998
Thioridazine HCl oral solution concentrate 30 mg/ml [3.3 MB] Pharmaceutical Associates, Inc. 040187 8/28/1996 3/27/1998
Thioridazine HCl oral solution concentrate 100 mg/ml [3.3 MB] Hi-Tech Pharmacal Co., Inc. 040126 8/16/1996 2/6/1998
Tolmetin Sodium Tablets USP, 600 mg (base). [2.1 MB] Lemmon Company 74729 2/27/97 4/9/99
Trazodone Hydrochloride Tablets USP, 150 mg. [3 MB] Lemmon Company 74357 4/30/97 4/7/99
Triamcinolone Acetonide cream 0.1% [601 KB] Taro Pharmaceuticals 040039 11/26/1997 4/27/1998
Triamterene and Hydrochlorothiazide capsules [7 MB] Mylan Pharmaceuticals 074701 7/6/1996 1/14/1998
Triamterene & Hydrochlorothiazide Capsules USP, 37.5 mg/25 mg. [3.7 MB] Geneva Pharmaceuticals, Inc. 74821 6/5/97 4/9/99
Triamterene & Hydrochlorothiazide Capsules USP, 37.5 mg/25 mg. [2.9 MB] Geneva Pharmaceuticals, Inc. 74857 9/9/97 4/12/99
Trimethoprim Sulfate and Polymyxin B Sulfaste Ophthalmic Solution [920 KB] Bausch and Lomb 064120 7/14/1997 3/19/1998
Trivora-21 & Trivora-28 (Levonorgestrel & Ethinyl Estradiol Tablets, USP), Triphasic Regimen. [3.7 MB] G. D. Searle & Co. 74538 12/18/97 4/7/99
Verapamil Hydrochloride Extended-release Tablets, 240 mg. [5.4 MB] Mylan Pharmaceuticals, Inc. 74587 10/8/97 4/13/99
Warfarin Sodium Tablets 1 mg, 2 mg, 2.5 mg, 4 mg, 5 mg, 7.5 mg, and 10 mg [2.3 MB] Barr Laboratories, Inc. 040145 3/26/1997 3/23/1998
Warfarin Sodium Tablets USP, 1 mg, 2 mg, 2.5 mg, 4 mg, 5 mg, 7.5 mg and 10 mg. [2.7 MB] Invamed Inc. 40196 9/30/1997 4/1/1999

 

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