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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 012248

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NDA 012248 describes PLEGINE, which is a drug marketed by Wyeth Ayerst and is included in one NDA. Additional details are available on the PLEGINE profile page.

The generic ingredient in PLEGINE 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 012248

Tradename:	PLEGINE
Applicant:	Wyeth Ayerst
Ingredient:	phendimetrazine tartrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	35MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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