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Last Updated: December 11, 2025

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, Aurobindo Pharma Usa, Chartwell Rx, Dr Reddys Labs Ltd, Elite Labs Inc, Prinston Inc, Sandoz Inc, Watson Labs Inc, Accord Hlthcare, Alembic Ltd, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Hikma, MLV, Orbion Pharms, Pharmobedient, and Zydus Lifesciences, and is included in twenty-one 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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.25MG BASE
Approval Date:	Jun 1, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Jun 1, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Jun 1, 2009	TE:	AB	RLD:	No

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