Details for New Drug Application (NDA): 202428

NDA 202428 describes FABIOR, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the FABIOR profile page.

The generic ingredient in FABIOR 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 202428

Tradename:	FABIOR
Applicant:	Mayne Pharma
Ingredient:	tazarotene
Patents:	3

Pharmacology for NDA: 202428

Suppliers and Packaging for NDA: 202428

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428	NDA	Mayne Pharma	51862-295	51862-295-10	1 CAN in 1 CARTON (51862-295-10) / 100 g in 1 CAN
FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428	NDA AUTHORIZED GENERIC	Mayne Pharma Inc.	68308-685	68308-685-50	1 CAN in 1 CARTON (68308-685-50) / 50 g in 1 CAN

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	0.1%
Approval Date:	May 11, 2012	TE:		RLD:	Yes
Patent:	10,568,859	Patent Expiration:	Feb 24, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OF AGE OR OLDER
Patent:	10,688,071	Patent Expiration:	Feb 24, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OF AGE OR OLDER
Patent:	8,808,716	Patent Expiration:	Feb 24, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

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