Last Updated: September 24, 2026

Details for New Drug Application (NDA): 077126

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NDA 077126 describes AMIFOSTINE, which is a drug marketed by Eugia Pharma Speclts and Sun Pharm and is included in two NDAs. Additional details are available on the AMIFOSTINE profile page.

The generic ingredient in AMIFOSTINE is amifostine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the amifostine profile page.

Summary for 077126

Tradename:	AMIFOSTINE
Applicant:	Sun Pharm
Ingredient:	amifostine
Patents:	0

Medical Subject Heading (MeSH) Categories for 077126

Radiation-Protective Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Mar 14, 2008	TE:		RLD:	No

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