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Last Updated: July 7, 2020

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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. Nine 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 Allergan, Inc. 0023-9155 0023-9155-15 1 TUBE in 1 CARTON (0023-9155-15) > 3.5 g in 1 TUBE
AVAGE tazarotene CREAM;TOPICAL 021184 NDA Allergan, Inc. 0023-9155 0023-9155-30 1 TUBE in 1 CARTON (0023-9155-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Sep 29, 2000TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Sep 29, 2000TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Sep 30, 2002TE:ABRLD:Yes

Expired US Patents for NDA 021184

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

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