Last Updated: September 24, 2026

Details for New Drug Application (NDA): 080694

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NDA 080694 describes CORTISONE ACETATE, which is a drug marketed by Pharmacia And Upjohn, Watson Labs, Barr, Chartwell Molecular, Elkins Sinn, Everylife, Heather, Hikma Intl Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Panray, Purepac Pharm, Vitarine, and Whiteworth Town Plsn, and is included in eighteen NDAs. It is available from one supplier. Additional details are available on the CORTISONE ACETATE profile page.

The generic ingredient in CORTISONE ACETATE is cortisone acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cortisone acetate profile page.

Summary for 080694

Tradename:	CORTISONE ACETATE
Applicant:	Chartwell Molecular
Ingredient:	cortisone acetate
Patents:	0

Pharmacology for NDA: 080694

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 080694

Anti-Inflammatory Agents

Suppliers and Packaging for NDA: 080694

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CORTISONE ACETATE	cortisone acetate	TABLET;ORAL	080694	ANDA	Chartwell RX, LLC	62135-173	62135-173-30	30 TABLET in 1 PACKAGE (62135-173-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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