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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 072640


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NDA 072640 describes CLOTRIMAZOLE, which is a drug marketed by Fougera Pharms, Glenmark Pharms, Taro, P And L, Novitium Pharma, Sciegen Pharms Inc, Teva, Trupharma, Hikma, Padagis Us, Thinq Pharm-cro Pvt, Actavis Mid Atlantic, and Glenmark Speclt, and is included in nineteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.
Summary for 072640
Tradename:CLOTRIMAZOLE
Applicant:Taro
Ingredient:clotrimazole
Patents:0
Pharmacology for NDA: 072640
Medical Subject Heading (MeSH) Categories for 072640
Suppliers and Packaging for NDA: 072640
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE clotrimazole CREAM;TOPICAL 072640 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1275 51672-1275-1 1 TUBE in 1 CARTON (51672-1275-1) / 15 g in 1 TUBE
CLOTRIMAZOLE clotrimazole CREAM;TOPICAL 072640 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1275 51672-1275-2 1 TUBE in 1 CARTON (51672-1275-2) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Aug 31, 1993TE:ABRLD:No

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