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… Oxandrin (oxandrolone) Tablets, Bio-Technology General NDA 13-718/S-022 4/21/03 Oxandrin (oxandrolone) Tablets Bio-Technology General NDA 13-718/S-020 & S-021   For the latest approval information, locate this drug using this index.