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Details for New Drug Application (NDA): 040368

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NDA 040368 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-eight 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: 040368

Impax Pharms
orphenadrine citrate
Therapeutic Class:Skeletal Muscle Relaxants

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
TABLET, EXTENDED RELEASE;ORAL 040368 ANDA Impax Generics 0115-2011 0115-2011-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-2011-01)
orphenadrine citrate
TABLET, EXTENDED RELEASE;ORAL 040368 ANDA Impax Generics 0115-2011 0115-2011-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-2011-02)

Summary for product number 001

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

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