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Generated: July 28, 2017

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Details for New Drug Application (NDA): 088167

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NDA 088167 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Taro, Akorn, Pharmafair, Identi Pharms Inc, Perrigo New York, Morton Grove, Gavis Pharms Llc, G And W Labs, G And W Labs Inc, Usl Pharma, Pharmaderm, Perrigo Israel, Alpharma Us Pharms, Bausch And Lomb, Fougera Pharms Inc, Lyne, and Actavis Labs Ut Inc, and is included in forty-five NDAs. It is available from fourteen suppliers. Additional details are available on the FLUOCINOLONE ACETONIDE profile page.

The generic ingredient in FLUOCINOLONE ACETONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for NDA: 088167

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Ophthalmic Agents
Otic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 088167

Suppliers and Packaging for NDA: 088167

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
SOLUTION;TOPICAL 088167 ANDA E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. 0168-0059 0168-0059-60 60 mL in 1 BOTTLE (0168-0059-60)
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
SOLUTION;TOPICAL 088167 ANDA Physicians Total Care, Inc. 54868-2264 54868-2264-1 1 BOTTLE in 1 CARTON (54868-2264-1) > 60 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.01%
Approval Date:Dec 16, 1982TE:ATRLD:No


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Serving 500+ biopharmaceutical companies globally:

Argus Health
Citi
Federal Trade Commission
Fuji
Cantor Fitzgerald
UBS
US Department of Justice
QuintilesIMS
McKesson
Harvard Business School

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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