Details for New Drug Application (NDA): 020221

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NDA 020221 describes ETHYOL, which is a drug marketed by Clinigen and is included in one NDA. Additional details are available on the ETHYOL profile page.

The generic ingredient in ETHYOL is amifostine. There are six drug master file entries for this compound. Additional details are available on the amifostine profile page.

Summary for 020221

Tradename:	ETHYOL
Applicant:	Clinigen
Ingredient:	amifostine
Patents:	0

Medical Subject Heading (MeSH) Categories for 020221

Radiation-Protective Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Dec 8, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	375MG/VIAL
Approval Date:	Sep 10, 1999	TE:		RLD:	No

Expired US Patents for NDA 020221

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Clinigen	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999	⤷ Sign Up	⤷ Sign Up
Clinigen	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999	⤷ Sign Up	⤷ Sign Up
Clinigen	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-001	Dec 8, 1995	⤷ Sign Up	⤷ Sign Up
Clinigen	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-001	Dec 8, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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