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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

Eisai Inc
eribulin mesylate

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:Nov 15, 2015
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.