Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.