Details for New Drug Application (NDA): 040463

NDA 040463 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 040463

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

Pharmacology for NDA: 040463

Physiological Effect

Centrally-mediated Muscle Relaxation

Suppliers and Packaging for NDA: 040463

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ORPHENADRINE CITRATE	orphenadrine citrate	INJECTABLE;INJECTION	040463	ANDA	Hikma Pharmaceuticals USA Inc.	0641-6182	0641-6182-25	25 BOX in 1 BOX (0641-6182-25) / 10 VIAL in 1 BOX (0641-6182-10) / 2 mL in 1 VIAL (0641-6182-01)
ORPHENADRINE CITRATE	orphenadrine citrate	INJECTABLE;INJECTION	040463	ANDA	REMEDYREPACK INC.	70518-3823	70518-3823-0	10 VIAL in 1 BOX (70518-3823-0) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	30MG/ML
Approval Date:	Mar 4, 2003	TE:	AP	RLD:	No

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