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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 083790

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NDA 083790 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 083790

Tradename:	PHENDIMETRAZINE TARTRATE
Applicant:	Numark
Ingredient:	phendimetrazine tartrate
Patents:	0

Profile for product number 001

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

Profile for product number 002

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

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