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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 214136

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NDA 214136 describes TAZAROTENE, which is a drug marketed by Cosette, Fougera Pharms Inc, Padagis Israel, Taro, and Solaris Pharma Corp, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the TAZAROTENE profile page.

The generic ingredient in TAZAROTENE is tazarotene. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tazarotene profile page.

Summary for 214136

Tradename:	TAZAROTENE
Applicant:	Cosette
Ingredient:	tazarotene
Patents:	0

Pharmacology for NDA: 214136

Suppliers and Packaging for NDA: 214136

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAZAROTENE	tazarotene	GEL;TOPICAL	214136	ANDA	Cosette Pharmaceuticals, Inc.	0713-0804	0713-0804-31	1 TUBE in 1 CARTON (0713-0804-31) / 30 g in 1 TUBE
TAZAROTENE	tazarotene	GEL;TOPICAL	214136	ANDA	Cosette Pharmaceuticals, Inc.	0713-0804	0713-0804-99	1 TUBE in 1 CARTON (0713-0804-99) / 100 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.1%
Approval Date:	Sep 13, 2022	TE:	AB	RLD:	No

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