Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg, Apotex Corp. ANDA 74-737 10/28/98 10/28/98 Captopril and Hydrochlorothiazide TabletsUSP, 25 mg/15 mg, 25 mg/25 mg, 50 mg/15 mg, 50 mg/25 mg Zenith Goldline ANDA 75-055 CAPTOPRIL Tablet; 100MG CAPTOPRIL APOTHECON | 074472 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL APOTHECON | 074472 CAPTOPRIL Tablet; 25MG CAPTOPRIL APOTHECON | 074472 CAPTOPRIL Tablet; 50MG CAPTOPRIL APOTHECON | 074423 CAPTOPRIL Tablet; 100MG CAPTOPRIL CLONMEL | 074423 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL CLONMEL | 074423 CAPTOPRIL Tablet; 25MG CAPTOPRIL CLONMEL | 074423 CAPTOPRIL Tablet; 50MG CAPTOPRIL CLONMEL | 074462 CAPTOPRIL Tablet; 100MG CAPTOPRIL Copley | 074462 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Copley | 074462 CAPTOPRIL Tablet; 25MG CAPTOPRIL Copley | 074462 CAPTOPRIL Tablet; 50MG CAPTOPRIL Copley | 074748 CAPTOPRIL Tablet; 100MG CAPTOPRIL Egis | 074748 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Egis | 074748 CAPTOPRIL Tablet; 25MG CAPTOPRIL Egis | 074748 CAPTOPRIL Tablet; 50MG CAPTOPRIL Egis | 074418 CAPTOPRIL Tablet; 100MG CAPTOPRIL ENDO | 074418 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL ENDO | 074418 CAPTOPRIL Tablet; 25MG CAPTOPRIL ENDO | 074418 CAPTOPRIL Tablet; 50MG CAPTOPRIL ENDO | 074519 CAPTOPRIL Tablet; 100MG CAPTOPRIL Eon | 074519 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Eon | 074519 CAPTOPRIL Tablet; 25MG CAPTOPRIL Eon | 074519 CAPTOPRIL Tablet; 50MG CAPTOPRIL Eon | 074363 CAPTOPRIL Tablet; 100MG CAPTOPRIL Geneva | 074363 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Geneva | 074363 CAPTOPRIL Tablet; 25MG CAPTOPRIL Geneva | 074363 CAPTOPRIL Tablet; 50MG CAPTOPRIL Geneva | 074481 CAPTOPRIL Tablet; 100MG CAPTOPRIL Geneva TECH | 074481 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Geneva TECH | 074481 CAPTOPRIL Tablet; 25MG CAPTOPRIL Geneva TECH | 074481 CAPTOPRIL Tablet; 50MG CAPTOPRIL Geneva TECH | 074477 CAPTOPRIL Tablet; 100MG CAPTOPRIL HALLMARK | 074477 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL HALLMARK | 074477 CAPTOPRIL Tablet; 25MG CAPTOPRIL HALLMARK | 074477 CAPTOPRIL Tablet; 50MG CAPTOPRIL HALLMARK | 074590 CAPTOPRIL Tablet; 100MG CAPTOPRIL Ivax | 074590 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Ivax | 074590 CAPTOPRIL Tablet; 25MG CAPTOPRIL Ivax | 074590 CAPTOPRIL Tablet; 50MG CAPTOPRIL Ivax | 074434 CAPTOPRIL Tablet; 100MG CAPTOPRIL Mylan | 074434 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Mylan | 074434 CAPTOPRIL Tablet; 25MG CAPTOPRIL Mylan | 074434 CAPTOPRIL Tablet; 50MG CAPTOPRIL Mylan | 074493 CAPTOPRIL Tablet; 100MG CAPTOPRIL Par 018343 CAPTOPRIL Tablet; 100MG CAPOTEN Par 018343 CAPTOPRIL Tablet; 12.5MG CAPOTEN Par | 074493 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Par | 074493 CAPTOPRIL Tablet; 25MG CAPTOPRIL Par 018343 CAPTOPRIL Tablet; 25MG CAPOTEN Par 018343 CAPTOPRIL Tablet; 50MG CAPOTEN Par | 074493 CAPTOPRIL Tablet; 50MG CAPTOPRIL Par | 074677 CAPTOPRIL Tablet; 100MG CAPTOPRIL STASON | 074677 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL STASON | 074677 CAPTOPRIL Tablet; 25MG CAPTOPRIL STASON | 074677 CAPTOPRIL Tablet; 50MG CAPTOPRIL STASON | 074322 CAPTOPRIL Tablet; 100MG CAPTOPRIL Teva | 074483 CAPTOPRIL Tablet; 100MG CAPTOPRIL Teva | 074433 CAPTOPRIL Tablet; 100MG CAPTOPRIL Teva | 074483 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Teva | 074322 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Teva | 074433 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Teva | 074433 CAPTOPRIL Tablet; 25MG CAPTOPRIL Teva | 074322 CAPTOPRIL Tablet; 25MG CAPTOPRIL Teva | 074483 CAPTOPRIL Tablet; 25MG CAPTOPRIL Teva | 074483 CAPTOPRIL Tablet; 50MG CAPTOPRIL Teva | 074322 CAPTOPRIL Tablet; 50MG CAPTOPRIL Teva | 074433 CAPTOPRIL Tablet; 50MG CAPTOPRIL Teva | 074737 CAPTOPRIL Tablet; 100MG CAPTOPRIL Torpharm | 074737 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Torpharm | 074737 CAPTOPRIL Tablet; 25MG CAPTOPRIL Torpharm | 074737 CAPTOPRIL Tablet; 50MG CAPTOPRIL Torpharm | 074451 CAPTOPRIL Tablet; 100MG CAPTOPRIL Watson | 074386 CAPTOPRIL Tablet; 100MG CAPTOPRIL Watson | 074576 CAPTOPRIL Tablet; 100MG CAPTOPRIL Watson | 074386 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Watson | 074576 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Watson | 074451 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Watson | 074451 CAPTOPRIL Tablet; 25MG CAPTOPRIL Watson | 074576 CAPTOPRIL Tablet; 25MG CAPTOPRIL Watson | 074386 CAPTOPRIL Tablet; 25MG CAPTOPRIL Watson | 074386 CAPTOPRIL Tablet; 50MG CAPTOPRIL Watson | 074576 CAPTOPRIL Tablet; 50MG CAPTOPRIL Watson | 074451 CAPTOPRIL Tablet; 50MG CAPTOPRIL Watson | 074505 CAPTOPRIL Tablet; 100MG CAPTOPRIL West Ward | 074505 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL West Ward | 074505 CAPTOPRIL Tablet; 25MG CAPTOPRIL West Ward | 074505 CAPTOPRIL Tablet; 50MG CAPTOPRIL West Ward | 074532 CAPTOPRIL Tablet; 100MG CAPTOPRIL Wockhardt | 074532 CAPTOPRIL Tablet; 12.5MG CAPTOPRIL Wockhardt | 074532 CAPTOPRIL Tablet; 25MG CAPTOPRIL Wockhardt | 074532 CAPTOPRIL Tablet; 50MG CAPTOPRIL Wockhardt 018709 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 25MG;15MG CAPOZIDE 25/15 APOTHECON 018709 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 25MG;25MG CAPOZIDE 25/25 APOTHECON 018709 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 50MG;15MG CAPOZIDE 50/15 APOTHECON 018709 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 50MG;25MG CAPOZIDE 50/25 APOTHECON | 074788 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 25MG;15MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE ENDO | 074788 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 25MG;25MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE ENDO | 074788 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 50MG;15MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE ENDO | 074788 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 50MG;25MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE ENDO 075055 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 25MG;15MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE Ivax 075055 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 25MG;25MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE Ivax 075055 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 50MG;15MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE Ivax 075055 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 50MG;25MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE Ivax | 074896 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 25MG;15MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE Mylan | 074896 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 25MG;25MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE Mylan | 074896 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 50MG;15MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE Mylan | 074896 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 50MG;25MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE Mylan | 074827 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 25MG;15MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE Teva | 074827 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 25MG;25MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE Teva | 074827 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 50MG;15MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE Teva | 074827 CAPTOPRIL; HYDROCHLOROTHIAZIDE Tablet; 50MG;25MG CAPTOPRIL AND HYDROCHLOROTHIAZIDE Teva | Capoten (captopril) Tablets, Par Pharmaceutical | Capozide (Captopril Hydrochlorothiazide) Tablets, Bristol-Myers Squibb, Labeling Revision | Capoten (captopril) Tablets, Par Pharmaceutical, Inc., Labeling Revision | Capozide (captopril and hydrochlorothiazide) Tablets, Bristol-Myers Squibb, Labeling Revision | Capoten (captopril) Tablets, Par Pharmaceutical, Inc., Labeling Revision | Capoten (captopril) Tablets, Par Pharmaceutical, Inc., Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com