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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 217075

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NDA 217075 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 217075

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

Pharmacology for NDA: 217075

Suppliers and Packaging for NDA: 217075

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAZAROTENE	tazarotene	CREAM;TOPICAL	217075	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-706	45802-706-94	1 TUBE in 1 CARTON (45802-706-94) / 30 g in 1 TUBE
TAZAROTENE	tazarotene	CREAM;TOPICAL	217075	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-706	45802-706-96	1 TUBE in 1 CARTON (45802-706-96) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Jul 15, 2024	TE:	AB	RLD:	No
Regulatory Exclusivity Expiration:	Mar 8, 2025
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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