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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 090869


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NDA 090869 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 090869
Tradename:ROPINIROLE HYDROCHLORIDE
Applicant:Actavis Elizabeth
Ingredient:ropinirole hydrochloride
Patents:0
Pharmacology for NDA: 090869
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 090869
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 090869 ANDA Actavis Pharma, Inc. 0228-3640 0228-3640-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3640-03)
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 090869 ANDA Actavis Pharma, Inc. 0228-3658 0228-3658-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3658-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 2MG BASE
Approval Date:May 17, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 4MG BASE
Approval Date:May 17, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 6MG BASE
Approval Date:May 17, 2012TE:ABRLD:No

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