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

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