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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 074580


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NDA 074580 describes CLOTRIMAZOLE, which is a drug marketed by Fougera Pharms, Glenmark Pharms, Taro, P And L, Novitium Pharma, Sciegen Pharms Inc, Tasman Pharma, Teva, Hikma, Padagis Us, and Actavis Mid Atlantic, and is included in eighteen NDAs. It is available from twenty-four 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. Fifteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.
Summary for 074580
Tradename:CLOTRIMAZOLE
Applicant:Taro
Ingredient:clotrimazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074580
Medical Subject Heading (MeSH) Categories for 074580
Suppliers and Packaging for NDA: 074580
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE clotrimazole SOLUTION;TOPICAL 074580 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1260 51672-1260-3 1 BOTTLE, PLASTIC in 1 CARTON (51672-1260-3) / 30 mL in 1 BOTTLE, PLASTIC
CLOTRIMAZOLE clotrimazole SOLUTION;TOPICAL 074580 ANDA RPK Pharmaceuticals, Inc. 53002-8400 53002-8400-2 1 BOTTLE, PLASTIC in 1 CARTON (53002-8400-2) / 30 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength1%
Approval Date:Jul 29, 1996TE:ATRLD:No

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