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… Ethambutol Hydrochloride Tablets USP, 400 mg, Barr Laboartories, ANDA 76-057 11/26/01 4/16/03 Ethambutol Hydrochloride Tablets USP, 100 mg and 400 mg. West-ward Pharmaceutical Corp. ANDA 75-095 Myambutol (ethambutol hydrochloride), 100 mg, 400 mg, Wyeth NDA 16-320/S-057, S-058 Myambutol (ethmbutol hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc.   For the latest approval information, locate this drug using this index.