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Generated: January 20, 2019

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Details for New Drug Application (NDA): 022529

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NDA 022529 describes BELVIQ, which is a drug marketed by Eisai Inc and is included in two NDAs. It is available from one supplier. There are fifteen patents protecting this drug and two Paragraph IV challenges. Additional details are available on the BELVIQ profile page.

The generic ingredient in BELVIQ is lorcaserin hydrochloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lorcaserin hydrochloride profile page.
Summary for 022529
Tradename:BELVIQ
Applicant:Eisai Inc
Ingredient:lorcaserin hydrochloride
Patents:15
Formulation / Manufacturing:see details
Pharmacology for NDA: 022529
Suppliers and Packaging for NDA: 022529
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BELVIQ lorcaserin hydrochloride TABLET;ORAL 022529 NDA Eisai Inc. 62856-529 62856-529-60 60 TABLET in 1 BOTTLE (62856-529-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 27, 2012TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 10, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD FOR CHRONIC WEIGHT MANAGEMENT BY CONTROLLING WEIGHT GAIN
Patent:➤ Sign UpPatent Expiration:Apr 10, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD FOR CHRONIC WEIGHT MANAGEMENT BY DECREASING FOOD INTAKE
Patent:➤ Sign UpPatent Expiration:Apr 10, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD FOR CHRONIC WEIGHT MANAGEMENT BY INDUCING SATIETY

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