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Last Updated: March 30, 2023

Details for New Drug Application (NDA): 020766

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NDA 020766 describes XENICAL, which is a drug marketed by Cheplapharm and is included in one NDA. It is available from one supplier. Additional details are available on the XENICAL profile page.

The generic ingredient in XENICAL is orlistat. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the orlistat profile page.
Summary for 020766
Formulation / Manufacturing:see details
Pharmacology for NDA: 020766
Mechanism of ActionLipase Inhibitors
Suppliers and Packaging for NDA: 020766
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XENICAL orlistat CAPSULE;ORAL 020766 NDA H2-Pharma LLC 61269-460 61269-460-90 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-460-90)
XENICAL orlistat CAPSULE;ORAL 020766 NDA AUTHORIZED GENERIC H2-Pharma LLC 61269-565 61269-565-90 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-565-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength120MG
Approval Date:Apr 23, 1999TE:RLD:Yes

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