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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Baxter
McKinsey
Accenture
Moodys
Novartis
Teva
Mallinckrodt
Fish and Richardson
Argus Health

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201576

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NDA 201576 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 thirty-one 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-three suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 201576
Tradename:ROPINIROLE HYDROCHLORIDE
Applicant:Dr Reddys Labs Ltd
Ingredient:ropinirole hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 201576
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 201576
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 201576 ANDA Dr. Reddys Laboratories Limited 55111-659 55111-659-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-659-05)
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 201576 ANDA Dr. Reddys Laboratories Limited 55111-659 55111-659-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-659-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 2MG BASE
Approval Date:Jun 6, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 4MG BASE
Approval Date:Jun 6, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 6MG BASE
Approval Date:Jun 6, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
UBS
Teva
Baxter
US Department of Justice
Fuji
Harvard Business School
Queensland Health
Farmers Insurance

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