Last Updated: November 9, 2026

Details for New Drug Application (NDA): 012157

NDA 012157 describes NORFLEX, which is a drug marketed by Pai Holdings Pharm and Bausch and is included in two NDAs. Additional details are available on the NORFLEX profile page.

The generic ingredient in NORFLEX is orphenadrine citrate. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the orphenadrine citrate profile page.

Summary for 012157

Tradename:	NORFLEX
Applicant:	Bausch
Ingredient:	orphenadrine citrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	Yes

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