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Details for New Drug Application (NDA): 076367

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NDA 076367 describes AMCINONIDE, which is a drug marketed by Taro Pharm Inds and Fougera Pharms and is included in five NDAs. It is available from two suppliers. Additional details are available on the AMCINONIDE profile page.

The generic ingredient in AMCINONIDE is amcinonide. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amcinonide profile page.

Summary for NDA: 076367

Tradename:
AMCINONIDE
Applicant:
Taro Pharm Inds
Ingredient:
amcinonide
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 076367

Suppliers and Packaging for NDA: 076367

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMCINONIDE
amcinonide
OINTMENT;TOPICAL 076367 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4060 51672-4060-1 1 TUBE in 1 CARTON (51672-4060-1) > 15 g in 1 TUBE
AMCINONIDE
amcinonide
OINTMENT;TOPICAL 076367 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4060 51672-4060-2 1 TUBE in 1 CARTON (51672-4060-2) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.1%
Approval Date:Mar 19, 2003TE:ABRLD:No


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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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