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Last Updated: November 14, 2024

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, Chartwell Rx, Dr Reddys Labs Ltd, Mylan Pharms Inc, Prinston Inc, Sandoz Inc, Watson Labs Inc, Accord Hlthcare, Alembic Ltd, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Hikma, MLV, Norvium Bioscience, Orbion Pharms, and Zydus Lifesciences, and is included in twenty NDAs. It is available from twenty-four 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. Twenty-four suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 090411
Tradename:ROPINIROLE HYDROCHLORIDE
Applicant:Zydus Lifesciences
Ingredient:ropinirole hydrochloride
Patents:0
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 Zydus Lifesciences Limited 65841-712 65841-712-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-712-01)
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 090411 ANDA Zydus Lifesciences Limited 65841-712 65841-712-10 1000 TABLET, FILM COATED in 1 BOTTLE (65841-712-10)

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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