Details for New Drug Application (NDA): 020600

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NDA 020600 describes TAZORAC, which is a drug marketed by Almirall and is included in two NDAs. It is available from two suppliers. Additional details are available on the TAZORAC profile page.

The generic ingredient in TAZORAC 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 020600

Tradename:	TAZORAC
Applicant:	Almirall
Ingredient:	tazarotene
Patents:	0

Pharmacology for NDA: 020600

Suppliers and Packaging for NDA: 020600

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAZORAC	tazarotene	GEL;TOPICAL	020600	NDA	Almirall, LLC	16110-042	16110-042-10	1 TUBE in 1 CARTON (16110-042-10) / 100 g in 1 TUBE
TAZORAC	tazarotene	GEL;TOPICAL	020600	NDA	Almirall, LLC	16110-042	16110-042-30	1 TUBE in 1 CARTON (16110-042-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.05%
Approval Date:	Jun 13, 1997	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.1%
Approval Date:	Jun 13, 1997	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020600

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-001	Jun 13, 1997	⤷ Get Started Free	⤷ Get Started Free
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-002	Jun 13, 1997	⤷ Get Started Free	⤷ Get Started Free
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-002	Jun 13, 1997	⤷ Get Started Free	⤷ Get Started Free
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-002	Jun 13, 1997	⤷ Get Started Free	⤷ Get Started Free
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-001	Jun 13, 1997	⤷ Get Started Free	⤷ Get Started Free
Almirall	TAZORAC	tazarotene	GEL;TOPICAL	020600-001	Jun 13, 1997	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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