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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 217250

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NDA 217250 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 217250

Tradename:	ERIBULIN MESYLATE
Applicant:	Baxter Hlthcare Corp
Ingredient:	eribulin mesylate
Patents:	0

Pharmacology for NDA: 217250

Physiological Effect	Microtubule Inhibition

Suppliers and Packaging for NDA: 217250

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	217250	ANDA	Baxter Healthcare Corporation	10019-080	10019-080-01	1 VIAL, SINGLE-DOSE in 1 CARTON (10019-080-01) / 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:	Oct 1, 2024	TE:	AP	RLD:	No

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