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Generated: November 20, 2018

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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 two suppliers. There is one patent protecting this drug. 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. Three suppliers are listed for this compound. Additional details are available on the orlistat profile page.
Summary for 020766
Tradename:XENICAL
Applicant:Cheplapharm
Ingredient:orlistat
Patents:1
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 Genentech, Inc. 0004-0257 0004-0257-52 90 CAPSULE in 1 BOTTLE, PLASTIC (0004-0257-52)
XENICAL orlistat CAPSULE;ORAL 020766 NDA H2-Pharma LLC 61269-460 61269-460-90 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-460-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength120MG
Approval Date:Apr 23, 1999TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 6, 2018Product Flag?Substance Flag?Delist Request?Y

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