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FDA Approval Activities for this Drug…
Altace (ramipril) Capsules, 1.25, 2.5, 5, and 10 mg, King NDA 19-901/S-035 7/10/02 7/15/02 Altace (ramipril) Capsules, 1.25, 2.5, 5, and 10 mg, King NDA 19-901/S-034 8/2/02 8/6/02 Altace (ramipril) Capsules,1.25, 2.5, 5, & 10 mg Hoechst Marion Roussel, NDA 19-901/S-025 12/16/98 3/13/00 Altace (ramipril) Capsules , 1.25, 2.5, 5, and 10 mg, King NDA 19-901/S-028 10/4/00 Altace Indication: Reduction in risk of myocardial infarction, stroke, and death from cardiovascular causes RAMIPRIL Capsule; 1.25MG ALTACE KING 019901 RAMIPRIL Capsule; 10MG ALTACE KING 019901 RAMIPRIL Capsule; 2.5MG ALTACE KING 019901 RAMIPRIL Capsule; 5MG ALTACE KING | Altace (ramipril) Capsules, King Pharma, Labeling Revision | Altace (ramipril) Capsules, King Pharmaceuticals, Labeling Revision | Ramipril Capsules, Roxane Labs, Tentative Approval | Ramipril Capsules, Sandoz Inc., Tentative Approval
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