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 Drug Recalls 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… Bisoprolol Fumarate Tablets, 5 and 10 mg, Copley Pharmaceutical, ANDA: 75-644 6/26/01 Bisoprolol Fumarate Tablets, 5 mg and 10 mg, Eon Labs Manfacturing, ANDA 75-643 11/16/00 11/17/00 Bisoprolol Fumarate Tablets, 5 mg and 10 mg, Mutual Pharmaceutical Co., ANDA 75-474 10/25/02 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, Mylan ANDA: 75-768 9/25/00 11/7/00 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, Teva ANDA: 75-686 1/19/01 3/5/01 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, Purepac Pharmaceutical Co. ANDA: 75-672 9/25/00 11/7/00 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, (Tentatively Approved: 5/11/2000) Purepac Pharmaceutical Co. ANDA: 75-672 5/11/00 5/22/00 Bisoprolol Fumarate and Hydrochlorothiazide Tablets,2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg.6.25 mg, Apothecon, ANDA 75-642 12/27/00 3/5/01 Bisoprolol Fumarate and Hydrochlorothiazide Tablets,2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg.6.25 mg, Zenith Goldline ANDA 75-632 9/27/00 11/7/00 Bisoprolol Fumarate and Hydrochlorothiazide Tablets,2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg.6.25 mg, Eon Labs Manfacturing, ANDA 75-579 9/25/00 11/7/00 Bisoprolol Fumarate and Hydrochlorothiazide Tablets,2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg.6.25 mg, (tentatively Approved 3/2/00) Eon Labs Manfacturing, ANDA 75-579 3/2/00 3/7/00 Bisoprolol Fumarate and Hydrochlorothiazide Tablets,2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg.6.25 mg, Invamed, ANDA 75-527 9/25/00 11/6/00 Bisoprolol Fumarate and Hydrochlorothiazide Tablets,2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg.6.25 mg, (tentatively Approved 3/31/00) Invamed, ANDA 75-527 3/31/00 4/4/00 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, Chelsea , ANDA: 75-469 9/25/00 11/6/00 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, (Tentatively Approved: 4/10/2000) Chelsea , ANDA: 75-469 Zebeta (Bisoprolol Fumarate) Tablets, 5 & 10 mg Wyeth-Ayerst NDA 19-982/S5 6/23/98 8/1/01 Zebeta (Bisoprolol Fumarate) Tablets, 5 & 10 mg Lederle NDA 19-982/S6 Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets and Zebeta (bisoprolol fumarate) Tablets, 2.5/6.25 mg, 5/6.25 mg, and 10/6.25 mg & 5 and 10 mg, respectively, Wyeth NDAs 20-186/S-015 and 19-982/S-010 | BISOPROLOL FUMARATE Tablet; 10MG BISOPROLOL FUMARATE Copley | 075644 BISOPROLOL FUMARATE Tablet; 5MG BISOPROLOL FUMARATE Copley | 019982 BISOPROLOL FUMARATE Tablet; 10MG ZEBETA DURAMED Barr 019982 | BISOPROLOL FUMARATE Tablet; 5MG ZEBETA DURAMED Barr 075643 | BISOPROLOL FUMARATE Tablet; 10MG BISOPROLOL FUMARATE Eon 075643 | BISOPROLOL FUMARATE Tablet; 5MG BISOPROLOL FUMARATE Eon 075474 | BISOPROLOL FUMARATE Tablet; 10MG BISOPROLOL FUMARATE Mutual | 075474 BISOPROLOL FUMARATE Tablet; 5MG BISOPROLOL FUMARATE Mutual | 020186 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;6.25MG ZIAC DURAMED Barr | 020186 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 2.5MG;6.25MG ZIAC DURAMED Barr 020186 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;6.25MG ZIAC DURAMED Barr | 075579 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Eon | 075579 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 2.5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Eon | 075579 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Eon | 075527 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Geneva TECH | 075527 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 2.5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Geneva TECH 075527 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Geneva TECH | 075632 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Ivax 075632 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 2.5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Ivax 075632 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Ivax 075768 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Mylan | 075768 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 2.5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Mylan | 075768 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Mylan | 075672 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Purepac 075672 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 2.5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Purepac | 075672 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Purepac 075686 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Teva | 075686 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 2.5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Teva | 075686 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Teva | 075469 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Watson 075469 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 2.5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Watson | 075469 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;6.25MG BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Watson | Bisoprolol Fumarate Tablets, Aurobindo Pharma, Approval | Zebeta (bisoprolol fumarate) Tablets, Duramed Pharma, Labeling Revision | Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets, Duramed Pharma, Labeling Revision | Bisoprolol Fumarate Tablets, Unichem Laboratories Ltd., Approval | Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets, Duramed Pharmaceuticals, 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 | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2009 Betterchem.com