Last Updated: September 24, 2026

Details for New Drug Application (NDA): 218047

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NDA 218047 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, Natco, Sandoz, and Xgen Pharms, and is included in ten 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. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.

Summary for 218047

Tradename:	ERIBULIN MESYLATE
Applicant:	Gland
Ingredient:	eribulin mesylate
Patents:	0

Pharmacology for NDA: 218047

Physiological Effect	Microtubule Inhibition

Suppliers and Packaging for NDA: 218047

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	218047	ANDA	Apotex Corp.	60505-6289	60505-6289-0	1 VIAL, SINGLE-DOSE in 1 CARTON (60505-6289-0) / 2 mL in 1 VIAL, SINGLE-DOSE
ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	218047	ANDA	Apotex Corp.	60505-6435	60505-6435-0	1 VIAL, SINGLE-DOSE in 1 CARTON (60505-6435-0) / 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:	Apr 5, 2024	TE:	AP	RLD:	No

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