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… Primaxin I.M. (imipenem and cilastatin) Injectable Suspension & Primaxin I.V., Merck & Company NDA 50-587/S58 & 50-630/S21 3/4/03 3/10/03 Primaxin I.M. (imipenem and cilastatin) Injectable Suspension & Primaxin I.V., Merck & Company NDA 50-587/S53 & 50-630/S17 11/30/01 2/12/02 Primaxin I.M. (imipenem and cilastatin) Injectable Suspension, Merck & Company NDA 50-638/S015 2/4/99 7/18/01 Primaxin I.V./imipenem and cilastatin Injection Merck NDA 50-587/S048 PRIMAXIN IM Injectable (Imipenem and Cilastatin), Merck & Co. PRIMAXIN(tm) IV for Injection (Imipenem and Cilastatin), Merck & Co.   For the latest approval information, locate this drug using this index.