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Generated: January 16, 2019

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Details for New Drug Application (NDA): 021887

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NDA 021887 describes ALLI, which is a drug marketed by Glaxosmithkline Cons and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. 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:Glaxosmithkline Cons
Ingredient:orlistat
Patents:1
Formulation / Manufacturing:see details
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 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0461 0135-0461-01 60 CAPSULE in 1 BOTTLE (0135-0461-01)
ALLI orlistat CAPSULE;ORAL 021887 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) 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
Patent:➤ Sign UpPatent Expiration:Jan 6, 2018Product Flag?YSubstance Flag?Delist Request?

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