You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078110


✉ Email this page to a colleague

« Back to Dashboard


NDA 078110 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 Generics, Hikma, MLV, Mylan, Orbion Pharms, and Zydus Lifesciences, and is included in twenty NDAs. It is available from twenty-five 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-five suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 078110
Tradename:ROPINIROLE HYDROCHLORIDE
Applicant:Prinston Inc
Ingredient:ropinirole hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078110
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 078110
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 078110 ANDA SOLCO HEALTHCARE US, LLC 43547-268 43547-268-10 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-268-10)
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 078110 ANDA SOLCO HEALTHCARE US, LLC 43547-268 43547-268-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-268-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.25MG BASE
Approval Date:May 5, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:May 5, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:May 5, 2008TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.