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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091395

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NDA 091395 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 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-two suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 091395
Tradename:ROPINIROLE HYDROCHLORIDE
Applicant:Wockhardt Ltd
Ingredient:ropinirole hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091395
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 091395
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 091395 ANDA Wockhardt Limited 55648-771 55648-771-01 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-771-01)
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 091395 ANDA Wockhardt Limited 55648-771 55648-771-02 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-771-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 2MG BASE
Approval Date:Aug 27, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 4MG BASE
Approval Date:Aug 27, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 6MG BASE
Approval Date:Aug 27, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Covington
Merck
Colorcon
Cipla
Julphar
Baxter
Johnson and Johnson
AstraZeneca
McKesson

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