Details for New Drug Application (NDA): 091042

NDA 091042 describes PHENDIMETRAZINE TARTRATE, which is a drug marketed by Graham Dm, Virtus, Sandoz, Vitarine, Barr, Chartwell, Chartwell Rx, Elite Labs Inc, Ferndale Labs, Inwood Labs, Ivax Pharms, Ivax Sub Teva Pharms, Kv Pharm, Kvk Tech, Mfg Chemists, Nexgen Pharma Inc, Nostrum Labs Inc, Numark, Pvt Form, Solvay, Upsher Smith Labs, Usl Pharma, and Watson Labs, and is included in sixty-five NDAs. It is available from twelve suppliers. Additional details are available on the PHENDIMETRAZINE TARTRATE profile page.

The generic ingredient in PHENDIMETRAZINE TARTRATE is phendimetrazine tartrate. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phendimetrazine tartrate profile page.

Summary for 091042

Tradename:	PHENDIMETRAZINE TARTRATE
Applicant:	Kvk Tech
Ingredient:	phendimetrazine tartrate
Patents:	0

Pharmacology for NDA: 091042

Physiological Effect

Appetite Suppression Increased Sympathetic Activity

Suppliers and Packaging for NDA: 091042

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	TABLET;ORAL	091042	ANDA	KVK-TECH, INC	10702-045	10702-045-01	100 TABLET in 1 BOTTLE (10702-045-01)
PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	TABLET;ORAL	091042	ANDA	KVK-TECH, INC	10702-045	10702-045-03	30 TABLET in 1 BOTTLE (10702-045-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	35MG
Approval Date:	Aug 31, 2010	TE:	AA	RLD:	No

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