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Details for New Drug Application (NDA): 208524

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NDA 208524 describes BELVIQ XR, which is a drug marketed by Eisai Inc and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the BELVIQ XR profile page.

The generic ingredient in BELVIQ XR 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 NDA: 208524

Eisai Inc
lorcaserin hydrochloride
Formulation / Manufacturing:see details

Pharmacology for NDA: 208524

Suppliers and Packaging for NDA: 208524

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lorcaserin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 208524 NDA Eisai Inc. 62856-535 62856-535-30 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62856-535-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jul 15, 2016TE:RLD:Yes
Patent:8,168,624Patent Expiration:Apr 18, 2029Product Flag?YSubstance Flag?YDelist Request?
Patent:8,697,686Patent Expiration:Dec 20, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:8,946,207Patent Expiration:Jun 16, 2024Product Flag?YSubstance Flag?Delist Request?

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