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Generated: November 18, 2018

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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 Hlthcare and is included in one NDA. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the amifostine profile page.
Summary for 020221
Tradename:ETHYOL
Applicant:Clinigen Hlthcare
Ingredient:amifostine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020221
Medical Subject Heading (MeSH) Categories for 020221
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 Bedford Laboratories 55390-308 55390-308-03 3 VIAL, SINGLE-USE in 1 CARTON (55390-308-03) > 10 mL in 1 VIAL, SINGLE-USE
ETHYOL amifostine INJECTABLE;INJECTION 020221 NDA Cumberland Pharmaceuticals Inc. 66220-017 66220-017-03 3 VIAL, SINGLE-USE in 1 CARTON (66220-017-03) > 10 mL in 1 VIAL, SINGLE-USE

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

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