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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Boehringer Ingelheim
Medtronic
Chubb
Mallinckrodt
Harvard Business School
Julphar
Dow

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040368

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NDA 040368 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 thirty-one 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 040368
Tradename:ORPHENADRINE CITRATE
Applicant:Impax Pharms
Ingredient:orphenadrine citrate
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 040368
Suppliers and Packaging for NDA: 040368
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORPHENADRINE CITRATE orphenadrine citrate TABLET, EXTENDED RELEASE;ORAL 040368 ANDA Impax Generics 0115-2011 N 0115-2011-01
ORPHENADRINE CITRATE orphenadrine citrate TABLET, EXTENDED RELEASE;ORAL 040368 ANDA Impax Generics 0115-2011 N 0115-2011-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Jun 23, 2000TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
Mallinckrodt
Baxter
McKinsey
Accenture
Moodys
Merck
Express Scripts

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