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Generated: December 10, 2018

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Details for New Drug Application (NDA): 074905

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NDA 074905 describes FLUOCINONIDE, which is a drug marketed by Amneal Pharms Llc, Fougera Pharms Inc, G And W Labs Inc, Glenmark Generics, Perrigo Israel, Perrigo New York, Taro, Teligent Pharma Inc, Teva, Cnty Line Pharms, Fougera Pharms, Novel Labs Inc, Glasshouse Pharms, Macleods Pharms Ltd, Teva Pharms, Zydus Pharms Usa Inc, Glenmark Pharms Ltd, and Taro Pharm Inds Ltd, and is included in thirty-eight NDAs. It is available from thirty-four 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-four suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 074905
Tradename:FLUOCINONIDE
Applicant:Fougera Pharms
Ingredient:fluocinonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074905
Medical Subject Heading (MeSH) Categories for 074905
Suppliers and Packaging for NDA: 074905
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINONIDE fluocinonide OINTMENT;TOPICAL 074905 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0140 0168-0140-15 1 TUBE in 1 CARTON (0168-0140-15) > 15 g in 1 TUBE
FLUOCINONIDE fluocinonide OINTMENT;TOPICAL 074905 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0140 0168-0140-30 1 TUBE in 1 CARTON (0168-0140-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Aug 26, 1997TE:ABRLD:No

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