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Last Updated: May 24, 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
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: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 TAZORAC tazarotene CREAM;TOPICAL 021184-002 Sep 29, 2000 ⤷  Sign Up ⤷  Sign Up
Allergan AVAGE tazarotene CREAM;TOPICAL 021184-003 Sep 30, 2002 ⤷  Sign Up ⤷  Sign Up
Allergan TAZORAC tazarotene CREAM;TOPICAL 021184-001 Sep 29, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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