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

Last Updated: December 29, 2025

Details for New Drug Application (NDA): 091282

✉ Email this page to a colleague

« Back to Dashboard

NDA 091282 describes FLUOCINONIDE, which is a drug marketed by Amneal, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, Padagis Israel, Pai Holdings Pharm, Perrigo New York, Sun Pharma Canada, Teva, Zydus Lifesciences, Alvogen, Padagis Us, Chartwell Rx, Fougera Pharms, Xiromed, Encube Ethicals, Macleods Pharms Ltd, Novel Labs Inc, Quagen, Sciegen Pharms Inc, Teva Pharms, Zydus Pharms, and Taro, and is included in forty-five NDAs. It is available from twenty-six suppliers. Additional details are available on the FLUOCINONIDE profile page.

The generic ingredient in FLUOCINONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for 091282

Tradename:	FLUOCINONIDE
Applicant:	Glenmark Pharms Ltd
Ingredient:	fluocinonide
Patents:	0

Pharmacology for NDA: 091282

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 091282

Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 091282

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	091282	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-505	68462-505-35	30 g in 1 TUBE (68462-505-35)
FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	091282	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-505	68462-505-65	60 g in 1 TUBE (68462-505-65)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	Jul 14, 2014	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.