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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078338

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NDA 078338 describes CLOTRIMAZOLE, which is a drug marketed by Fougera Pharms, Glenmark Pharms, Taro, Actavis Mid Atlantic, Teva, Paddock Llc, and West-ward Pharms Int, and is included in fifteen NDAs. It is available from eighteen suppliers. Additional details are available on the CLOTRIMAZOLE profile page.

The generic ingredient in CLOTRIMAZOLE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.
Summary for 078338
Tradename:CLOTRIMAZOLE
Applicant:Fougera Pharms
Ingredient:clotrimazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 078338
Ingredient-typeAzoles
Medical Subject Heading (MeSH) Categories for 078338
Suppliers and Packaging for NDA: 078338
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE clotrimazole CREAM;TOPICAL 078338 ANDA E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. 0168-0133 N 0168-0133-15
CLOTRIMAZOLE clotrimazole CREAM;TOPICAL 078338 ANDA E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. 0168-0133 N 0168-0133-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Sep 2, 2008TE:ABRLD:No

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