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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 018074

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NDA 018074 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 018074

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

Pharmacology for NDA: 018074

Physiological Effect	Appetite Suppression Increased Sympathetic Activity

Suppliers and Packaging for NDA: 018074

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	018074	NDA	Acertis Pharmaceuticals, LLC	72989-409	72989-409-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72989-409-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	105MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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