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Federal Trade Commission
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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012546

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NDA 012546 describes TENUATE DOSPAN, which is a drug marketed by Actavis Labs Ut Inc and is included in one NDA. It is available from eight suppliers. Additional details are available on the TENUATE DOSPAN profile page.

The generic ingredient in TENUATE DOSPAN is diethylpropion hydrochloride. There are eleven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the diethylpropion hydrochloride profile page.
Summary for 012546
Tradename:TENUATE DOSPAN
Applicant:Actavis Labs Ut Inc
Ingredient:diethylpropion hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 012546
Medical Subject Heading (MeSH) Categories for 012546
Suppliers and Packaging for NDA: 012546
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TENUATE DOSPAN diethylpropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 012546 NDA Actavis Pharma, Inc. 0591-0782 N 0591-0782-01
TENUATE DOSPAN diethylpropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 012546 NDA Apotheca Inc. 12634-691 N 12634-691-63

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength75MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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