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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076065

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NDA 076065 describes AMCINONIDE, which is a drug marketed by Fougera Pharms and Taro Pharm Inds and is included in five NDAs. It is available from two suppliers. Additional details are available on the AMCINONIDE profile page.

The generic ingredient in AMCINONIDE is amcinonide. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amcinonide profile page.

Summary for 076065

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 076065

Suppliers and Packaging for NDA: 076065

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMCINONIDE amcinonide CREAM;TOPICAL 076065 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0278 0168-0278-30 1 TUBE in 1 CARTON (0168-0278-30) > 30 g in 1 TUBE
AMCINONIDE amcinonide CREAM;TOPICAL 076065 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0278 0168-0278-15 1 TUBE in 1 CARTON (0168-0278-15) > 15 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:May 15, 2003TE:ABRLD:No


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