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 | Xenical (Orlistat) Capsules, Hoffman-LaRoche, Efficacy Supplement with Clinical Data to Support | Xenical (orlistat) Capsules, Hoffman- LaRoche, Labeling Revision | Xenical (orlistat) Capsules, Hoffmann-La Roche, Labeling Revision | Alli (60 mg orlistat) capsules, GlaxoSmithKline, Approval