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Last Updated: June 22, 2021

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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 Nostrum Labs Inc and is included in four NDAs. It is available from one supplier. 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. Seven suppliers are listed for this compound. Additional details are available on the diethylpropion hydrochloride profile page.
Summary for 011722
Applicant:Nostrum Labs Inc
Ingredient:diethylpropion hydrochloride
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 Apotheca Inc. 12634-530 12634-530-00 10 TABLET in 1 BOTTLE (12634-530-00)
TENUATE diethylpropion hydrochloride TABLET;ORAL 011722 NDA Apotheca Inc. 12634-530 12634-530-01 100 TABLET in 1 BOTTLE (12634-530-01)

Profile for product number 002

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

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