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Details for New Drug Application (NDA): 072494

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NDA 072494 describes FLUOCINONIDE EMULSIFIED BASE, which is a drug marketed by G And W Labs Inc, Fougera Pharms, Teva, and Taro, and is included in four NDAs. It is available from four suppliers. Additional details are available on the FLUOCINONIDE EMULSIFIED BASE profile page.

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

Summary for NDA: 072494

Tradename:
FLUOCINONIDE EMULSIFIED BASE
Applicant:
Taro
Ingredient:
fluocinonide
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 072494

Suppliers and Packaging for NDA: 072494

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINONIDE EMULSIFIED BASE
fluocinonide
CREAM;TOPICAL 072494 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1254 51672-1254-1 1 TUBE in 1 CARTON (51672-1254-1) > 15 g in 1 TUBE
FLUOCINONIDE EMULSIFIED BASE
fluocinonide
CREAM;TOPICAL 072494 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1254 51672-1254-2 1 TUBE in 1 CARTON (51672-1254-2) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Jan 19, 1989TE:AB2RLD:Yes


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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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