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Generated: May 26, 2017

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Details for New Drug Application (NDA): 201212

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NDA 201212 describes DIETHYLPROPION HYDROCHLORIDE, which is a drug marketed by Avanthi Inc, Sandoz, Corepharma, Watson Labs, Teva, Ucb Inc, Tg United Labs, and Lannett Holdings Inc, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the DIETHYLPROPION HYDROCHLORIDE profile page.

The generic ingredient in DIETHYLPROPION HYDROCHLORIDE 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: 201212

Formulation / Manufacturing:see details

Pharmacology for NDA: 201212

Suppliers and Packaging for NDA: 201212

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
diethylpropion hydrochloride
TABLET;ORAL 201212 ANDA KVK-TECH, INC 10702-044 10702-044-01 100 TABLET in 1 BOTTLE (10702-044-01)
diethylpropion hydrochloride
TABLET;ORAL 201212 ANDA KVK-TECH, INC 10702-044 10702-044-03 30 TABLET in 1 BOTTLE (10702-044-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Dec 22, 2010TE:AARLD:No

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