Last Updated: September 24, 2026

Details for New Drug Application (NDA): 087378

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NDA 087378 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 is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phendimetrazine tartrate profile page.

Summary for 087378

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	105MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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