You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for New Drug Application (NDA): 202428


✉ Email this page to a colleague

« Back to Dashboard


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
Formulation / Manufacturing:see details
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:RXDosage:AEROSOL, FOAM;TOPICALStrength0.1%
Approval Date:May 11, 2012TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 24, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OF AGE OR OLDER
Patent:⤷  Try a TrialPatent Expiration:Feb 24, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OF AGE OR OLDER
Patent:⤷  Try a TrialPatent Expiration:Feb 24, 2030Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.