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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 020221

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NDA 020221 describes ETHYOL, which is a drug marketed by Cosette and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the amifostine profile page.

Summary for 020221

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

Pharmacology for NDA: 020221

Mechanism of Action	Free Radical Scavenging Activity

Medical Subject Heading (MeSH) Categories for 020221

Radiation-Protective Agents

Suppliers and Packaging for NDA: 020221

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETHYOL	amifostine	INJECTABLE;INJECTION	020221	NDA	Legacy Pharma USA Inc.	83107-030	83107-030-02	3 VIAL, SINGLE-DOSE in 1 CARTON (83107-030-02) / 10 mL in 1 VIAL, SINGLE-DOSE (83107-030-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
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
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999	5,242,471	⤷ Get Started Free
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-001	Dec 8, 1995	5,424,471	⤷ Get Started Free
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-001	Dec 8, 1995	5,591,731	⤷ Get Started Free
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-001	Dec 8, 1995	5,994,409	⤷ Get Started Free
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999	5,994,409	⤷ Get Started Free
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999	5,424,471	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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