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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 211882


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NDA 211882 describes ARAZLO, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ARAZLO profile page.

The generic ingredient in ARAZLO 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 211882
Tradename:ARAZLO
Applicant:Bausch
Ingredient:tazarotene
Patents:2
Pharmacology for NDA: 211882
Suppliers and Packaging for NDA: 211882
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARAZLO tazarotene LOTION;TOPICAL 211882 NDA Bausch Health US, LLC 0187-2098 0187-2098-10 10 TUBE in 1 CARTON (0187-2098-10) / 3 g in 1 TUBE (0187-2098-03)
ARAZLO tazarotene LOTION;TOPICAL 211882 NDA Bausch Health US, LLC 0187-2098 0187-2098-45 1 TUBE in 1 CARTON (0187-2098-45) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.045%
Approval Date:Dec 18, 2019TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 11, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER
Patent:⤷  Sign UpPatent Expiration:Jun 6, 2036Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 211882

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch ARAZLO tazarotene LOTION;TOPICAL 211882-001 Dec 18, 2019 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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