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… Purinethol (mercaptopurine) Tablets, SmithKlineBeecham dba GlaxoSmithKline NDA 09-053/S-022 1/10/03 1/23/03 1/23/03 Purinethol (mercaptopurine) Tablets, SmithKlineBeecham dba GlaxoSmithKline NDA 09-053/S-021 9/6/02 9/11/02 Purinethol (mercaptopurine) Tablets, 50 mg SmithKlineBeecham dba GlaxoSmithKline NDA 09-053/S-020 Mercaptopurine Tablets, Prometheus Laboratories Inc. Mercaptopurine Tablets, Roxane Laboratories Inc. Purinethol (mercaptopurine) Tablets, Teva Pharmaceuticals, Labeling Revision   For the latest approval information, locate this drug using this index.