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 three 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. Ten 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:	3

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:	RX	Dosage:	LOTION;TOPICAL			Strength	0.045%
Approval Date:	Dec 18, 2019	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	May 11, 2038	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER
Patent:	⤷ Get Started Free	Patent Expiration:	Jun 6, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	May 11, 2038	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER

Expired US Patents for NDA 211882

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

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