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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 040484

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NDA 040484 describes ORPHENADRINE CITRATE, which is a drug marketed by Hikma, Rising, Sagent Pharms, Watson Labs, Ascot, Lupin, Sandoz, Stevens J, and Unichem, and is included in fifteen NDAs. It is available from nineteen suppliers. Additional details are available on the ORPHENADRINE CITRATE profile page.

The generic ingredient in ORPHENADRINE CITRATE is aspirin; caffeine; orphenadrine citrate. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aspirin; caffeine; orphenadrine citrate profile page.

Summary for 040484

Tradename:	ORPHENADRINE CITRATE
Applicant:	Rising
Ingredient:	orphenadrine citrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	30MG/ML
Approval Date:	May 24, 2006	TE:	AP	RLD:	No

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