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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Argus Health
US Army
Daiichi Sankyo
Dow
Teva
Deloitte
Colorcon
Boehringer Ingelheim

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040484

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NDA 040484 describes ORPHENADRINE CITRATE, which is a drug marketed by Akorn, Sagent Pharms, Watson Labs, West-ward Pharms Int, Ascot, Gavis Pharms, Impax Pharms, Invagen Pharms, Sandoz, Tedor Pharma Inc, and Stevens J, and is included in fifteen NDAs. It is available from twenty-five 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. Additional details are available on the aspirin; caffeine; orphenadrine citrate profile page.
Summary for 040484
Tradename:ORPHENADRINE CITRATE
Applicant:Akorn
Ingredient:orphenadrine citrate
Patents:0
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 orphenadrine citrate INJECTABLE;INJECTION 040484 ANDA Akorn, Inc. 17478-538 N 17478-538-02

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Harvard Business School
Fish and Richardson
Baxter
Medtronic
Cantor Fitzgerald
AstraZeneca
Moodys
Fuji

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