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Last Updated: December 22, 2024

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 ActionLipase 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:OTCDosage:CAPSULE;ORALStrength60MG
Approval Date:Feb 7, 2007TE:RLD:Yes

Expired US Patents for NDA 021887

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

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