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Generated: April 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202428

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NDA 202428 describes FABIOR, which is a drug marketed by Mayne Pharma 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 FABIOR profile page.

The generic ingredient in FABIOR is tazarotene. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tazarotene profile page.
Summary for 202428
Applicant:Mayne Pharma
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 Mayne Pharma 51862-295 51862-295-50 1 CAN in 1 CARTON (51862-295-50) > 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:➤ Sign UpPatent Expiration:Feb 24, 2030Product Flag?YSubstance Flag?Delist Request?

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