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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 078468

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NDA 078468 describes CALCIPOTRIENE, which is a drug marketed by Chartwell Rx, Glenmark Speclt, Glenmark Pharms Inc, Cosette, Fougera Pharms, Hikma, Glenmark Pharms Ltd, Padagis Israel, and Taro, and is included in fourteen NDAs. It is available from six suppliers. Additional details are available on the CALCIPOTRIENE profile page.

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

Summary for 078468

Tradename:	CALCIPOTRIENE
Applicant:	Cosette
Ingredient:	calcipotriene
Patents:	0

Pharmacology for NDA: 078468

Suppliers and Packaging for NDA: 078468

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	078468	ANDA	Cosette Pharmaceuticals, Inc.	0713-0318	0713-0318-53	1 BOTTLE in 1 CARTON (0713-0318-53) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	0.005%
Approval Date:	Mar 24, 2011	TE:	AT	RLD:	No

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