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FDA Approval Activities for this Drug…
Fosinopril Sodium Tablets, 10, 20 & 40 mg, 7/10/2003 Geneva ANDA 76-188 7/10/03 Fosinopril Sodium Tablets, 10, 20 & 40 mg, 7/10/2003 Teva ANDA 76-139 Monopril (fosinopril soidum) Tablets, 10, 20, and 40 mg, Bristol-Myers Squibb Company NDA 19-915/S-037 5/27/03 8/25/03 Monopril (fosinopril soidum) Tablets, 10, 20, and 40 mg, Bristol-Myers Squibb Company NDA 19-915/S-032 Monopril and Monopril-HCT (fosinopril sodium/hydrochloride) Tablets, Bristol-Myers Fosinopril Sodium Tablets, Teva Fosinopril Sodium Tablets, Eon Labs, Fosinopril Sodium Tablets, Ranbaxy Fosinopril Sodium Tablets, Eon Labs Fosinopril Sodium & Hydrochlorothiazide Tablets, Ranbaxy, Tentative Approval | Fosinopril Sodium Tablets, Sandoz Inc., Approval | Fosinopril Sodium Tablets, Andrx Pharma, Approval | Fosinopril Sodium & Hydrochlorothiazide Tablets, Andrx Pharma, Approval | Fosinopril Sodium Tablets, Watson Labs, Approval | Fosinopril Sodium Tablets, Bristol Myers Squibb, Approval | Fosinopril Sodium & Hydrochlorothiazide Tablets, Watson Labs, Approval | Fosinopril Sodium and Hydrochlorothiazide Tablets, Sandoz, Approval | Fosinopril Sodium & Hydrochlorothiazide Tablets, Teva Pharma, Approval | Fosinopril Sodium & Hydrochlorothiazide Tablets, Genpharm, Approval | Fosinopril Sodium Tablets, Cobalt Pharmaceuticals, Approval | Monopril (fosinopril sodium) Tablets, Bristol-Myers Squibb, Labeling Revision | Monopril HCT (fosinopril and hydrochlorothiazide) Tablets, Bristol-Myers Squibb, Labeling Revision | Fosinopril Sodium and Hydrochlorothiazide Tablets, Aurobindo Pharma Ltd., Approval | Fosinopril Sodium and Hydrochlorothiazide Tablets, InvaGen Pharmaceuticals Inc., Approval | Fosinopril Sodium and Hydrochlorothiazide Tablets, Actavis Totowa LLC, Approval | Fosinopril Sodium Tablets, Aurobindo Pharma, Ltd., Approval
  
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