You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Details for New Drug Application (NDA): 019117


✉ Email this page to a colleague

« Back to Dashboard


NDA 019117 describes FLUOCINONIDE, which is a drug marketed by Amneal, Cosette, Encube, Fougera Pharms Inc, Glenmark Generics, Padagis Israel, Pai Holdings Pharm, Perrigo New York, Taro, Teva, Zydus Lifesciences, Alvogen, Padagis Us, Chartwell Rx, Fougera Pharms, Xiromed, Encube Ethicals, Macleods Pharms Ltd, Novel Labs Inc, Teva Pharms, Zydus Pharms, and Glenmark Pharms Ltd, and is included in forty-four NDAs. It is available from twenty-eight 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-five suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 019117
Tradename:FLUOCINONIDE
Applicant:Taro
Ingredient:fluocinonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019117
Medical Subject Heading (MeSH) Categories for 019117
Suppliers and Packaging for NDA: 019117
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINONIDE fluocinonide CREAM;TOPICAL 019117 NDA Taro Pharmaceuticals U.S.A., Inc. 51672-1253 51672-1253-1 1 TUBE in 1 CARTON (51672-1253-1) / 15 g in 1 TUBE
FLUOCINONIDE fluocinonide CREAM;TOPICAL 019117 NDA Taro Pharmaceuticals U.S.A., Inc. 51672-1253 51672-1253-2 1 TUBE in 1 CARTON (51672-1253-2) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 26, 1984TE:RLD:Yes

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. 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.