Details for New Drug Application (NDA): 213269

NDA 213269 describes CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, which is a drug marketed by Glenmark Pharms Ltd, Chartwell Rx, Padagis Israel, Cosette, and Taro, and is included in five NDAs. It is available from four suppliers. Additional details are available on the CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE profile page.

The generic ingredient in CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.

Summary for 213269

Tradename:	CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
Applicant:	Taro
Ingredient:	betamethasone dipropionate; calcipotriene
Patents:	0

Pharmacology for NDA: 213269

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 213269

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	213269	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-1402	51672-1402-4	1 BOTTLE in 1 CARTON (51672-1402-4) / 60 g in 1 BOTTLE
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	213269	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-1402	51672-1402-8	2 BOTTLE in 1 CARTON (51672-1402-8) / 60 g in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;TOPICAL			Strength	0.064%;0.005%
Approval Date:	Sep 2, 2020	TE:	AB	RLD:	No

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