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Details for New Drug Application (NDA): 040484

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NDA 040484 describes ORPHENADRINE CITRATE, which is a drug marketed by Watson Labs, Sandoz, Tedor Pharma Inc, Invagen Pharms, West-ward Pharms Int, Ascot, Impax Pharms, Akorn, Gavis Pharms, Sagent Pharms, and Stevens J, and is included in fifteen NDAs. It is available from twenty-nine 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-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin; caffeine; orphenadrine citrate profile page.

Summary for NDA: 040484

Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details

Pharmacology for NDA: 040484

Suppliers and Packaging for NDA: 040484

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
orphenadrine citrate
INJECTABLE;INJECTION 040484 ANDA Akorn, Inc. 17478-538 17478-538-02 10 VIAL in 1 CARTON (17478-538-02) > 2 mL in 1 VIAL
orphenadrine citrate
INJECTABLE;INJECTION 040484 ANDA A-S Medication Solutions 50090-2438 50090-2438-0 10 VIAL in 1 CARTON (50090-2438-0) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/ML
Approval Date:May 24, 2006TE:APRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.