Details for New Drug Application (NDA): 040762

NDA 040762 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 040762

Tradename:	PHENDIMETRAZINE TARTRATE
Applicant:	Elite Labs Inc
Ingredient:	phendimetrazine tartrate
Patents:	0

Pharmacology for NDA: 040762

Physiological Effect

Appetite Suppression Increased Sympathetic Activity

Suppliers and Packaging for NDA: 040762

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	TABLET;ORAL	040762	ANDA	Elite Laboratories, Inc	64850-440	64850-440-01	100 TABLET in 1 BOTTLE (64850-440-01)
PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	TABLET;ORAL	040762	ANDA	Elite Laboratories, Inc	64850-440	64850-440-10	1000 TABLET in 1 BOTTLE (64850-440-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	35MG
Approval Date:	Jan 28, 2008	TE:	AA	RLD:	No

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