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Details for New Drug Application (NDA): 202428

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NDA 202428 describes FABIOR, which is a drug marketed by Stiefel Labs Inc 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. Three suppliers are listed for this compound. Additional details are available on the tazarotene profile page.

Summary for NDA: 202428

Tradename:
FABIOR
Applicant:
Stiefel Labs Inc
Ingredient:
tazarotene
Patents:1
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202428

Ingredient-typeRetinoids

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 Stiefel Laboratories, Inc. 0145-0020 0145-0020-02 1 CAN in 1 CARTON (0145-0020-02) > 100 g in 1 CAN
FABIOR
tazarotene
AEROSOL, FOAM;TOPICAL 202428 NDA Stiefel Laboratories, Inc. 0145-0020 0145-0020-03 1 CAN in 1 CARTON (0145-0020-03) > 50 g in 1 CAN

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength0.1%
Approval Date:May 11, 2012TE:RLD:Yes
Patent:8,808,716Patent Expiration:Feb 24, 2030Product Flag?YSubstance Flag?Delist Request?


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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 verifification 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.

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