Details for New Drug Application (NDA): 076002

NDA 076002 describes CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, which is a drug marketed by Actavis Mid Atlantic, Fougera Pharms, Glenmark Speclt, 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. Sixteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.

Summary for 076002

Tradename:	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Applicant:	Actavis Mid Atlantic
Ingredient:	betamethasone dipropionate; clotrimazole
Patents:	0

Pharmacology for NDA: 076002

Mechanism of Action

Corticosteroid 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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	EQ 0.05% BASE;1%
Approval Date:	Aug 2, 2002	TE:	AB	RLD:	No

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