Details for New Drug Application (NDA): 210765

NDA 210765 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 210765

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

Pharmacology for NDA: 210765

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 210765

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	210765	ANDA	Cosette Pharmaceuticals, Inc.	0713-0848	0713-0848-60	1 BOTTLE in 1 CARTON (0713-0848-60) / 60 g in 1 BOTTLE
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	210765	ANDA	Cosette Pharmaceuticals, Inc.	0713-0848	0713-0848-92	2 BOTTLE in 1 CARTON (0713-0848-92) / 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:	May 11, 2020	TE:	AB	RLD:	No

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