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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019117

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NDA 019117 describes FLUOCINONIDE, which is a drug marketed by Fougera Pharms Inc, G And W Labs Inc, Glenmark Generics, Perrigo Israel, Perrigo New York, Taro, Teva, Cnty Line Pharms, Fougera Pharms, Novel Labs Inc, Fougera, and Teva Pharms, and is included in twenty-nine NDAs. It is available from twenty-eight suppliers. Additional details are available on the FLUOCINONIDE profile page.

The generic ingredient in FLUOCINONIDE is fluocinonide. There are nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.

Summary for 019117

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
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 Lake Erie Medical DBA Quality Care Products LLC 49999-172 49999-172-15 1 TUBE in 1 CARTON (49999-172-15) > 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Jun 26, 1984TE:AB1RLD:Yes


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