Last Updated: May 9, 2026

Details for New Drug Application (NDA): 040035

✉ Email this page to a colleague

« Back to Dashboard

NDA 040035 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Allied, Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Sun Pharma Canada, Usl Pharma, Amneal, Padagis Israel, Quagen, Rising, Sciegen Pharms, Tp Anda Holdings, Glenmark Pharms Ltd, Novel Labs Inc, Pharmaderm, Actavis Labs Ut Inc, Bausch And Lomb, Chartwell Rx, Encube Ethicals, Lupin, and Pai Holdings Pharm, and is included in fifty-six NDAs. It is available from thirteen suppliers. Additional details are available on the FLUOCINOLONE ACETONIDE profile page.

The generic ingredient in FLUOCINOLONE ACETONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for 040035

Tradename:	FLUOCINOLONE ACETONIDE
Applicant:	Sun Pharma Canada
Ingredient:	fluocinolone acetonide
Patents:	0

Medical Subject Heading (MeSH) Categories for 040035

Anti-Inflammatory Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.01%
Approval Date:	Oct 31, 1994	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.