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Generated: December 10, 2018

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Details for New Drug Application (NDA): 040463

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NDA 040463 describes ORPHENADRINE CITRATE, which is a drug marketed by Akorn, Sagent Pharms, Watson Labs, West-ward Pharms Int, Anda Repository, Ascot, Gavis Pharms, Impax Pharms, Invagen Pharms, Sandoz, and Stevens J, and is included in fifteen NDAs. It is available from twenty-nine 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-two 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 040463
Applicant:West-ward Pharms Int
Ingredient:orphenadrine citrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 040463
Suppliers and Packaging for NDA: 040463
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORPHENADRINE CITRATE orphenadrine citrate INJECTABLE;INJECTION 040463 ANDA West-Ward Pharmaceuticals Corp. 0641-6182 0641-6182-10 10 VIAL in 1 BOX (0641-6182-10) > 2 mL in 1 VIAL (0641-6182-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/ML
Approval Date:Mar 4, 2003TE:APRLD:No

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