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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208662

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NDA 208662 describes TAZAROTENE, which is a drug marketed by Cosette, Fougera Pharms Inc, Padagis Israel, Sun Pharma Canada, and Solaris Pharma Corp, and is included in nine 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. Ten suppliers are listed for this compound. Additional details are available on the tazarotene profile page.

Summary for 208662

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

Pharmacology for NDA: 208662

Suppliers and Packaging for NDA: 208662

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAZAROTENE	tazarotene	CREAM;TOPICAL	208662	ANDA	Cosette Pharmaceuticals, Inc.	0713-0670	0713-0670-31	1 TUBE in 1 CARTON (0713-0670-31) / 30 g in 1 TUBE
TAZAROTENE	tazarotene	CREAM;TOPICAL	208662	ANDA	Cosette Pharmaceuticals, Inc.	0713-0670	0713-0670-60	1 TUBE in 1 CARTON (0713-0670-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	Dec 22, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Mar 10, 2025	TE:	AB	RLD:	No

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