You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 13, 2025

Details for New Drug Application (NDA): 083759

✉ Email this page to a colleague

« Back to Dashboard

NDA 083759 describes HYDROCORTISONE ACETATE, which is a drug marketed by Cenci, Imperium, Parke Davis, Purepac Pharm, Bel Mar, Epic Pharma Llc, Watson Labs, Fera Pharms, X Gen Pharms, and Genus, and is included in thirteen NDAs. Additional details are available on the HYDROCORTISONE ACETATE profile page.

The generic ingredient in HYDROCORTISONE ACETATE is hydrocortisone acetate; pramoxine hydrochloride. There are sixty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.

Summary for 083759

Tradename:	HYDROCORTISONE ACETATE
Applicant:	Watson Labs
Ingredient:	hydrocortisone acetate
Patents:	0

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.