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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200462

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NDA 200462 describes ROPINIROLE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz Inc, Watson Labs Inc, Wockhardt Ltd, Accord Hlthcare, Alembic Ltd, Apotex, Epic Pharma Llc, G And W Labs Inc, Glenmark Generics, Mylan, Orchid Hlthcare, Prinston Inc, West-ward Pharms Int, Wockhardt, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from twenty-nine suppliers. Additional details are available on the ROPINIROLE HYDROCHLORIDE profile page.

The generic ingredient in ROPINIROLE HYDROCHLORIDE is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 200462
Tradename:ROPINIROLE HYDROCHLORIDE
Applicant:Mylan Pharms Inc
Ingredient:ropinirole hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200462
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 200462
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 200462 ANDA Mylan Pharmaceuticals Inc. 0378-4091 N 0378-4091-93
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 200462 ANDA Mylan Pharmaceuticals Inc. 0378-4093 N 0378-4093-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 2MG BASE
Approval Date:Oct 15, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 3MG BASE
Approval Date:Oct 15, 2012TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 4MG BASE
Approval Date:Oct 15, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Farmers Insurance
US Department of Justice
Queensland Health
Healthtrust
Medtronic
Deloitte
US Army
Express Scripts

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