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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 076516


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NDA 076516 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 fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.
Pharmacology for NDA: 076516
Suppliers and Packaging for NDA: 076516
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole LOTION;TOPICAL 076516 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0370 0168-0370-30 30 mL in 1 BOTTLE (0168-0370-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrengthEQ 0.05% BASE;1%
Approval Date:Jun 16, 2005TE:ABRLD:No

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