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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040327

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NDA 040327 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 040327
Tradename:ORPHENADRINE CITRATE
Applicant:Sandoz
Ingredient:orphenadrine citrate
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 040327
Suppliers and Packaging for NDA: 040327
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORPHENADRINE CITRATE orphenadrine citrate TABLET, EXTENDED RELEASE;ORAL 040327 ANDA Eon Labs, Inc. 0185-0022 N 0185-0022-10
ORPHENADRINE CITRATE orphenadrine citrate TABLET, EXTENDED RELEASE;ORAL 040327 ANDA Eon Labs, Inc. 0185-0022 N 0185-0022-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Feb 15, 2000TE:ABRLD:No

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