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. 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:	0

Pharmacology for NDA: 020766

Mechanism of Action	Lipase 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:	RX	Dosage:	CAPSULE;ORAL			Strength	120MG
Approval Date:	Apr 23, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 020766

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999	⤷ Sign Up	⤷ Sign Up
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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