Details for New Drug Application (NDA): 040327

NDA 040327 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 040327

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

Pharmacology for NDA: 040327

Physiological Effect

Centrally-mediated Muscle Relaxation

Suppliers and Packaging for NDA: 040327

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ORPHENADRINE CITRATE	orphenadrine citrate	TABLET, EXTENDED RELEASE;ORAL	040327	ANDA	Sandoz Inc	0185-0022	0185-0022-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0022-01)
ORPHENADRINE CITRATE	orphenadrine citrate	TABLET, EXTENDED RELEASE;ORAL	040327	ANDA	Proficient Rx LP	63187-632	63187-632-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-632-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Feb 15, 2000	TE:	AB	RLD:	No

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