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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 084303

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NDA 084303 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. Four suppliers are listed for this compound. Additional details are available on the aspirin; caffeine; orphenadrine citrate profile page.

Summary for 084303

Tradename:	ORPHENADRINE CITRATE
Applicant:	Watson Labs
Ingredient:	orphenadrine citrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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