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Generated: May 28, 2017

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Details for New Drug Application (NDA): 201532

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NDA 201532 describes HALAVEN, which is a drug marketed by Eisai Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the HALAVEN profile page.

The generic ingredient in HALAVEN is eribulin mesylate. One supplier is listed for this compound. Additional details are available on the eribulin mesylate profile page.

Summary for NDA: 201532


Pharmacology for NDA: 201532

Physiological EffectMicrotubule Inhibition

Suppliers and Packaging for NDA: 201532

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
eribulin mesylate
SOLUTION;INTRAVENOUS 201532 NDA Eisai Inc. 62856-389 62856-389-01 1 VIAL in 1 CARTON (62856-389-01) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1MG/2ML (0.5MG/ML)
Approval Date:Nov 15, 2010TE:RLD:Yes
Patent:6,214,865Patent Expiration:Jul 20, 2023Product Flag?Substance Flag?YDelist Request?
Patent:7,470,720Patent Expiration:Jun 16, 2019Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Jan 28, 2023
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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