FDA Approval Activities for this Drug…

Aggrastat (tirofiban hydrochloride) Premixed Injection, 0.05 mg/mL, Merck & Co., NDA 20-913/S10 5/17/02 5/23/02 Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Merck & Co., NDA 20-913/S9 & 20-912/S12 6/17/02 7/24/03 Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Merck & Co., NDA 20-913/S8 & 20-912/S9 7/24/02 8/6/02 Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Merck & Co., NDA 20-913/S7 & 20-912/S8 9/25/01 4/22/02 4/22/02 Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection,12.5 mg per 50 mL vial & Premixed 25 mg per 500 mL single dose container, Merck NDA 20-913/S6 & 20-912/S7 3/23/01 4/25/01 Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Merck NDA 20-913/S4 & 20-912/S4 1/11/00 6/6/01 Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Merck NDA 20-913/S1 & 20-912/S1 7/9/99 7/2/01 7/2/01 7/2/01 Aggrastat (tirofiban hydrochloride) Premixed Injection, Merck NDA 20-912/S13 2/28/03 3/10/03 Aggrastat (tirofiban hydrochloride) Injection Premixed 25 mg per 500 mL single dose container Merck NDA 20- 912 & 20-913

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