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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 021184

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NDA 021184 describes TAZORAC, which is a drug marketed by Allergan and is included in two NDAs. It is available from three 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. Eleven suppliers are listed for this compound. Additional details are available on the tazarotene profile page.

Summary for 021184

Tradename:	TAZORAC
Applicant:	Allergan
Ingredient:	tazarotene
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021184

Suppliers and Packaging for NDA: 021184

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AVAGE	tazarotene	CREAM;TOPICAL	021184	NDA	Almirall, LLC	16110-915	16110-915-30	1 TUBE in 1 CARTON (16110-915-30) / 30 g in 1 TUBE
AVAGE	tazarotene	CREAM;TOPICAL	021184	NDA	Almirall, LLC	16110-915	16110-915-60	1 TUBE in 1 CARTON (16110-915-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Sep 29, 2000	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	Sep 29, 2000	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	Sep 30, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021184

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	TAZORAC	tazarotene	CREAM;TOPICAL	021184-002	Sep 29, 2000	⤷ Try a Trial	⤷ Try a Trial
Allergan	AVAGE	tazarotene	CREAM;TOPICAL	021184-003	Sep 30, 2002	⤷ Try a Trial	⤷ Try a Trial
Allergan	TAZORAC	tazarotene	CREAM;TOPICAL	021184-001	Sep 29, 2000	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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