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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090585

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NDA 090585 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 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 090585
Applicant:Sagent Pharms
Ingredient:orphenadrine citrate
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 090585
Suppliers and Packaging for NDA: 090585
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORPHENADRINE CITRATE orphenadrine citrate INJECTABLE;INJECTION 090585 ANDA Sagent Pharmaceuticals 25021-651 N 25021-651-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/ML
Approval Date:Aug 30, 2011TE:APRLD:No

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Harvard Business School
Federal Trade Commission
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Daiichi Sankyo
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