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Generated: November 12, 2018

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Details for New Drug Application (NDA): 011722

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NDA 011722 describes TENUATE, which is a drug marketed by Sanofi Aventis Us and Teva Branded Pharm and is included in four NDAs. It is available from eight suppliers. Additional details are available on the TENUATE profile page.

The generic ingredient in TENUATE is diethylpropion hydrochloride. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the diethylpropion hydrochloride profile page.
Summary for 011722
Tradename:TENUATE
Applicant:Teva Branded Pharm
Ingredient:diethylpropion hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 011722
Medical Subject Heading (MeSH) Categories for 011722
Suppliers and Packaging for NDA: 011722
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TENUATE diethylpropion hydrochloride TABLET;ORAL 011722 NDA Actavis Pharma, Inc. 0591-0783 0591-0783-01 100 TABLET in 1 BOTTLE (0591-0783-01)
TENUATE diethylpropion hydrochloride TABLET;ORAL 011722 ANDA Blenheim Pharmacal, Inc. 10544-598 10544-598-28 28 TABLET in 1 BOTTLE (10544-598-28)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

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