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Details for New Drug Application (NDA): 076002

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NDA 076002 describes CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, which is a drug marketed by Actavis Mid Atlantic, Fougera Pharms, Taro, and Glenmark Pharms, and is included in six NDAs. It is available from fourteen suppliers. Additional details are available on the CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE profile page.

The generic ingredient in CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.

Summary for NDA: 076002

Pharmacology for NDA: 076002

Ingredient-typeAzoles
Mechanism of ActionCorticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 076002

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
betamethasone dipropionate; clotrimazole
CREAM;TOPICAL 076002 ANDA Actavis Pharma, Inc. 0472-0379 0472-0379-15 1 TUBE in 1 CARTON (0472-0379-15) > 15 g in 1 TUBE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
betamethasone dipropionate; clotrimazole
CREAM;TOPICAL 076002 ANDA Actavis Pharma, Inc. 0472-0379 0472-0379-45 1 TUBE in 1 CARTON (0472-0379-45) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrengthEQ 0.05% BASE;1%
Approval Date:Aug 2, 2002TE:ABRLD:No


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