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Generated: December 17, 2017

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Details for New Drug Application (NDA): 091158

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NDA 091158 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-two 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 091158

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Jul 27, 2012TE:ABRLD:No


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