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

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