Details for New Drug Application (NDA): 075502

NDA 075502 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 seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.

Summary for 075502

Tradename:	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Applicant:	Fougera Pharms
Ingredient:	betamethasone dipropionate; clotrimazole
Patents:	0

Pharmacology for NDA: 075502

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 075502

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	075502	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0258	0168-0258-15	15 g in 1 TUBE (0168-0258-15)
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	075502	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0258	0168-0258-46	45 g in 1 TUBE (0168-0258-46)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	EQ 0.05% BASE;1%
Approval Date:	Jun 5, 2001	TE:	AB	RLD:	No

Complete Access Available with Subscription