Last Updated: May 11, 2026

Details for New Drug Application (NDA): 219054

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NDA 219054 describes ERIBULIN MESYLATE, which is a drug marketed by Baxter Hlthcare Corp, Chia Tai Tianqing, Dr Reddys, Gland, Glenmark Pharms, Jiangxi Kvvit Pharm, Long Grove Pharms, Sandoz, and Xgen Pharms, and is included in nine NDAs. It is available from fourteen suppliers. Additional details are available on the ERIBULIN MESYLATE profile page.

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

Summary for 219054

Tradename:	ERIBULIN MESYLATE
Applicant:	Xgen Pharms
Ingredient:	eribulin mesylate
Patents:	0

Pharmacology for NDA: 219054

Physiological Effect	Microtubule Inhibition

Suppliers and Packaging for NDA: 219054

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	219054	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-2080	39822-2080-1	1 VIAL, SINGLE-DOSE in 1 CARTON (39822-2080-1) / 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:	Mar 16, 2026	TE:	AP	RLD:	No

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