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Serving leading biopharmaceutical companies globally:

US Department of Justice
Farmers Insurance

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076493

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NDA 076493 describes CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, which is a drug marketed by Actavis Mid Atlantic, Fougera Pharms, Glenmark Pharms, and Taro, and is included in six NDAs. It is available from sixteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.

Summary for 076493

Formulation / Manufacturing:see details

Pharmacology for NDA: 076493

Mechanism of ActionCorticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 076493

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole LOTION;TOPICAL 076493 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1308 51672-1308-3 1 BOTTLE in 1 CARTON (51672-1308-3) > 30 mL in 1 BOTTLE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole LOTION;TOPICAL 076493 ANDA Physicians Total Care, Inc. 54868-5232 54868-5232-0 1 BOTTLE in 1 CARTON (54868-5232-0) > 30 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrengthEQ 0.05% BASE;1%
Approval Date:Jul 28, 2004TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Argus Health

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