Last Updated: November 9, 2026

Details for New Drug Application (NDA): 013055

NDA 013055 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 013055

Tradename:	NORFLEX
Applicant:	Pai Holdings Pharm
Ingredient:	orphenadrine citrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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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