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Serving leading biopharmaceutical companies globally:

Argus Health
US Army
US Department of Justice
Queensland Health

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090411

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NDA 090411 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-one suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 090411
Applicant:Zydus Pharms Usa Inc
Ingredient:ropinirole hydrochloride
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090411
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 090411
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 090411 ANDA Cadila Healthcare Limited 65841-712 N 65841-712-10
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 090411 ANDA Cadila Healthcare Limited 65841-712 N 65841-712-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.25MG BASE
Approval Date:Jun 1, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:Jun 1, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Jun 1, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
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Harvard Business School
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