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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
US Army
UBS
Cipla
Daiichi Sankyo
Boehringer Ingelheim
QuintilesIMS
Johnson and Johnson
Chubb

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077852

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NDA 077852 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 077852
Tradename:ROPINIROLE HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:ropinirole hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077852
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 077852
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 077852 ANDA West-Ward Pharmaceuticals Corp. 0054-0116 N 0054-0116-25
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 077852 ANDA West-Ward Pharmaceuticals Corp. 0054-0117 N 0054-0117-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.25MG BASE
Approval Date:May 5, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:May 5, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:May 5, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Accenture
Fuji
Johnson and Johnson
UBS
Federal Trade Commission
Colorcon
Harvard Business School
Baxter

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