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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 091158

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NDA 091158 describes ORPHENADRINE CITRATE, which is a drug marketed by Hikma, Rising, Sagent Pharms, Watson Labs, Ascot, Bayshore Pharms Llc, Lupin, Sandoz, and Stevens J, and is included in fifteen NDAs. It is available from twenty 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 091158

Tradename:	ORPHENADRINE CITRATE
Applicant:	Bayshore Pharms Llc
Ingredient:	orphenadrine citrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Jul 27, 2012	TE:	AB	RLD:	No

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