Details for New Drug Application (NDA): 021887

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NDA 021887 describes ALLI, which is a drug marketed by Haleon Us Holdings and is included in one NDA. It is available from two suppliers. Additional details are available on the ALLI profile page.

The generic ingredient in ALLI 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 021887

Tradename:	ALLI
Applicant:	Haleon Us Holdings
Ingredient:	orlistat
Patents:	0

Pharmacology for NDA: 021887

Mechanism of Action	Lipase Inhibitors

Suppliers and Packaging for NDA: 021887

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALLI	orlistat	CAPSULE;ORAL	021887	NDA	Haleon US Holdings LLC	0135-0461	0135-0461-01	60 CAPSULE in 1 BOTTLE (0135-0461-01)
ALLI	orlistat	CAPSULE;ORAL	021887	NDA	Haleon US Holdings LLC	0135-0461	0135-0461-02	90 CAPSULE in 1 BOTTLE (0135-0461-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	60MG
Approval Date:	Feb 7, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 021887

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007	4,598,089	⤷ Get Started Free
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007	6,004,996	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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