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Last Updated: June 21, 2021

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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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020221
Paragraph IV (Patent) Challenges for 020221
Tradename Dosage Ingredient NDA Submissiondate
ETHYOL INJECTABLE;INJECTION amifostine 020221 2004-04-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Dec 8, 1995TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength375MG/VIAL
Approval Date:Sep 10, 1999TE:RLD:No

Expired US Patents for NDA 020221

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

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