Details for New Drug Application (NDA): 204363

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NDA 204363 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 are six drug master file entries for this compound. Additional details are available on the amifostine profile page.

Summary for 204363

Tradename:	AMIFOSTINE
Applicant:	Eugia Pharma Speclts
Ingredient:	amifostine
Patents:	0

Medical Subject Heading (MeSH) Categories for 204363

Radiation-Protective Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Jul 17, 2017	TE:		RLD:	No

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