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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 seven 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 NDA: 012546

Actavis Labs Ut Inc
diethylpropion hydrochloride
Formulation / Manufacturing:see details

Pharmacology for NDA: 012546

Suppliers and Packaging for NDA: 012546

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
diethylpropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL 012546 NDA Actavis Pharma, Inc. 0591-0782 0591-0782-01 100 TABLET in 1 BOTTLE (0591-0782-01)
diethylpropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL 012546 NDA Apotheca Inc. 12634-691 12634-691-00 10 TABLET in 1 BOTTLE (12634-691-00)

Summary 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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