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Last Updated: August 11, 2020

DrugPatentWatch Database Preview

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 is one patent 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. Nine 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:1
Formulation / Manufacturing:see details
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
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
Regulatory Exclusivity Expiration:Dec 18, 2022
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Aug 3, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER

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