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… Naltrexone Hydrochloride Tablets, 25, 50 & 100mg, Mallinckrodt, ANDA 76-264 3/22/02 4/11/03 Naltrexone Hydrochloride Tablets, 50 mg Barr ANDA 74-918 5/8/98 5/8/98 3/19/99 Naltrexone Hydrochloride Tablets USP, 50 mg, Eon Labs Manufacturing, ANDA 75-434 3/8/00 3/9/00 12/6/01 Naltrexone Hydrochloride Tablets, 50 mg Amide Pharmaceutical, ANDA 75-274 NALTREXONE HYDROCHLORIDE Tablet; 50MG NALTREXONE HCL Amide 074918 NALTREXONE HYDROCHLORIDE Tablet; 50MG NALTREXONE HCL Barr 018932 NALTREXONE HYDROCHLORIDE Tablet; 50MG REVIA Barr 075434 NALTREXONE HYDROCHLORIDE Tablet; 50MG NALTREXONE HCL Eon 076264 NALTREXONE HYDROCHLORIDE Tablet; 100MG NALTREXONE HCL Mallinckrodt 076264 NALTREXONE HYDROCHLORIDE Tablet; 25MG NALTREXONE HCL Mallinckrodt 076264 NALTREXONE HYDROCHLORIDE Tablet; 50MG NALTREXONE HCL Mallinckrodt   For the latest approval information, locate this drug using this index.