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Serving 500+ biopharmaceutical companies globally:

Merck
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Generated: June 25, 2017

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Details for New Drug Application (NDA): 200734

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NDA 200734 describes FLUOCINONIDE, which is a drug marketed by Taro, Fougera Pharms, Teva, Teva Pharms, Fougera Pharms Inc, Fougera, G And W Labs Inc, Perrigo Israel, Glenmark Generics, and Perrigo New York, and is included in twenty-six NDAs. It is available from twenty-five suppliers. Additional details are available on the FLUOCINONIDE profile page.

The generic ingredient in FLUOCINONIDE is fluocinonide. There are nine drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.

Summary for NDA: 200734

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

Pharmacology for NDA: 200734

Suppliers and Packaging for NDA: 200734

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINONIDE
fluocinonide
CREAM;TOPICAL 200734 ANDA Pharmaceutica North America, Inc 45861-064 45861-064-01 1 TUBE in 1 CARTON (45861-064-01) > 120 g in 1 TUBE
FLUOCINONIDE
fluocinonide
CREAM;TOPICAL 200734 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1353 51672-1353-2 1 TUBE in 1 CARTON (51672-1353-2) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Jul 14, 2014TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Mallinckrodt
Citi
Deloitte
Daiichi Sankyo
Queensland Health
Accenture
Teva
Fuji
Cipla

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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