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Serving 500+ biopharmaceutical companies globally:

Accenture
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Novartis
Covington
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Queensland Health

Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040284

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NDA 040284 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: 040284

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

Pharmacology for NDA: 040284

Suppliers and Packaging for NDA: 040284

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORPHENADRINE CITRATE
orphenadrine citrate
TABLET, EXTENDED RELEASE;ORAL 040284 ANDA Blenheim Pharmacal, Inc. 10544-283 10544-283-20 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (10544-283-20)
ORPHENADRINE CITRATE
orphenadrine citrate
TABLET, EXTENDED RELEASE;ORAL 040284 ANDA Rebel Distributors Corp 21695-099 21695-099-14 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-099-14)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Jun 19, 1998TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

McKesson
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Dow
Queensland Health
Fish and Richardson
Moodys
Boehringer Ingelheim
Daiichi Sankyo
Mallinckrodt
Teva

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