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… Xenical/Orlistat Capsules, 120 mg [patient instructions] Roche NDA 20-766 4/26/99 4/27/99 4/27/99 8/13/99 Xenical/Orlistat Capsules, 120 mg Roche NDA 20766/S7 6/25/01 6/25/01 Indication: XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats. Xenical (Orlistat) Capsules, Hoffman - La Roche, Inc., Labeling Revision   For the latest approval information, locate this drug using this index.