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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 Actavis Labs Ut Inc and Sanofi Aventis Us and is included in four NDAs. It is available from ten 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 NDA: 011722

Actavis Labs Ut Inc
diethylpropion hydrochloride

Pharmacology for NDA: 011722

Suppliers and Packaging for NDA: 011722

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
diethylpropion hydrochloride
TABLET;ORAL 011722 NDA Actavis Pharma, Inc. 0591-0783 0591-0783-01 100 TABLET in 1 BOTTLE (0591-0783-01)
diethylpropion hydrochloride
TABLET;ORAL 011722 ANDA Blenheim Pharmacal, Inc. 10544-598 10544-598-28 28 TABLET in 1 BOTTLE (10544-598-28)

Summary 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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