Details for New Drug Application (NDA): 202894

NDA 202894 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 202894

Tradename:	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Applicant:	Glenmark Speclt
Ingredient:	betamethasone dipropionate; clotrimazole
Patents:	0

Pharmacology for NDA: 202894

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 202894

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	202894	ANDA	Redpharm Drug	67296-1369	67296-1369-1	15 g in 1 TUBE (67296-1369-1)
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	202894	ANDA	NuCare Pharmaceuticals,Inc.	68071-4134	68071-4134-4	45 g in 1 BOX (68071-4134-4)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	EQ 0.05% BASE;1%
Approval Date:	Oct 30, 2015	TE:	AB	RLD:	No

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