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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075673

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NDA 075673 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 075673
Ingredient:betamethasone dipropionate; clotrimazole
Formulation / Manufacturing:see details
Pharmacology for NDA: 075673
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 075673
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 075673 ANDA NORTHSTAR RX LLC 16714-496 16714-496-02 1 TUBE in 1 CARTON (16714-496-02) > 45 g in 1 TUBE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 075673 ANDA NORTHSTAR RX LLC 16714-496 16714-496-01 1 TUBE in 1 CARTON (16714-496-01) > 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrengthEQ 0.05% BASE;1%
Approval Date:May 29, 2001TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Farmers Insurance
Queensland Health

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