Details for New Drug Application (NDA): 085588

NDA 085588 describes PHENDIMETRAZINE TARTRATE, which is a drug marketed by Acertis Pharms, 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, Mpp Pharma, Nexgen Pharma 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 085588

Tradename:	PHENDIMETRAZINE TARTRATE
Applicant:	Acertis Pharms
Ingredient:	phendimetrazine tartrate
Patents:	0

Pharmacology for NDA: 085588

Physiological Effect

Appetite Suppression Increased Sympathetic Activity

Suppliers and Packaging for NDA: 085588

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	TABLET;ORAL	085588	ANDA	Bryant Ranch Prepack	63629-2489	63629-2489-1	1000 TABLET in 1 BOTTLE (63629-2489-1)
PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	TABLET;ORAL	085588	ANDA	Virtus Pharmaceuticals, LLC	69543-410	69543-410-10	100 TABLET in 1 BOTTLE (69543-410-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	35MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AA	RLD:	No

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