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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 090585


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NDA 090585 describes ORPHENADRINE CITRATE, which is a drug marketed by Hikma, Rising, Sagent Pharms, Watson Labs, Ascot, Bayshore Pharms Llc, Impax Pharms, Lupin, Sandoz, and Stevens J, and is included in fifteen NDAs. It is available from nineteen 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. Three suppliers are listed for this compound. Additional details are available on the aspirin; caffeine; orphenadrine citrate profile page.
Summary for 090585
Tradename:ORPHENADRINE CITRATE
Applicant:Sagent Pharms
Ingredient:orphenadrine citrate
Patents:0
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 25021-651-02 10 VIAL in 1 CARTON (25021-651-02) / 2 mL in 1 VIAL

Profile for product number 001

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

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