Details for New Drug Application (NDA): 201212

NDA 201212 describes DIETHYLPROPION HYDROCHLORIDE, which is a drug marketed by Lannett Co Inc, Avanthi Inc, Chartwell Rx, Epic Pharma Llc, Sandoz, Teva, Ucb Inc, and Watson Labs, and is included in ten NDAs. It is available from thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the diethylpropion hydrochloride profile page.

Summary for 201212

Tradename:	DIETHYLPROPION HYDROCHLORIDE
Applicant:	Avanthi Inc
Ingredient:	diethylpropion hydrochloride
Patents:	0

Pharmacology for NDA: 201212

Physiological Effect

Appetite Suppression Increased Sympathetic Activity

Medical Subject Heading (MeSH) Categories for 201212

Appetite Depressants

Suppliers and Packaging for NDA: 201212

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Dec 22, 2010	TE:	AA	RLD:	No

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