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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 214850

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NDA 214850 describes ERIBULIN MESYLATE, which is a drug marketed by Baxter Hlthcare Corp, Gland Pharma Ltd, Jiangxi Qingfeng, and Long Grove Pharms, and is included in four NDAs. It is available from five suppliers. Additional details are available on the ERIBULIN MESYLATE profile page.

The generic ingredient in ERIBULIN MESYLATE is eribulin mesylate. Seven suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.

Summary for 214850

Tradename:	ERIBULIN MESYLATE
Applicant:	Long Grove Pharms
Ingredient:	eribulin mesylate
Patents:	0

Pharmacology for NDA: 214850

Physiological Effect	Microtubule Inhibition

Suppliers and Packaging for NDA: 214850

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	214850	ANDA	Long Grove Pharmaceuticals, LLC	81298-3890	81298-3890-1	1 VIAL, SINGLE-DOSE in 1 CARTON (81298-3890-1) / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1MG/2ML (0.5MG/ML)
Approval Date:	Jul 18, 2024	TE:	AP	RLD:	No

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