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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 213079

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NDA 213079 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 213079

Tradename:	TAZAROTENE
Applicant:	Padagis Israel
Ingredient:	tazarotene
Patents:	0

Pharmacology for NDA: 213079

Suppliers and Packaging for NDA: 213079

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAZAROTENE	tazarotene	GEL;TOPICAL	213079	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-436	45802-436-01	1 TUBE in 1 CARTON (45802-436-01) / 100 g in 1 TUBE
TAZAROTENE	tazarotene	GEL;TOPICAL	213079	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-436	45802-436-94	1 TUBE in 1 CARTON (45802-436-94) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.05%
Approval Date:	Apr 25, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.1%
Approval Date:	Apr 25, 2023	TE:	AB	RLD:	No

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