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Generated: April 25, 2017

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Details for New Drug Application (NDA): 075008

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NDA 075008 describes FLUOCINONIDE, which is a drug marketed by Taro, Fougera Pharms, Teva, Teva Pharms, Fougera Pharms Inc, Fougera, G And W Labs Inc, Perrigo Israel, Glenmark Generics, and Perrigo New York, and is included in twenty-six NDAs. It is available from twenty-five 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.

Summary for NDA: 075008

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 075008

Suppliers and Packaging for NDA: 075008

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OINTMENT;TOPICAL 075008 ANDA NORTHSTAR RX LLC 16714-502 16714-502-01 1 TUBE in 1 CARTON (16714-502-01) > 15 g in 1 TUBE
OINTMENT;TOPICAL 075008 ANDA NORTHSTAR RX LLC 16714-502 16714-502-02 1 TUBE in 1 CARTON (16714-502-02) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Jun 30, 1999TE:ABRLD:No

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