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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078881

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NDA 078881 describes ROPINIROLE HYDROCHLORIDE, which is a drug marketed by Prinston Inc, Zydus Pharms Usa Inc, Accord Hlthcare, Alembic Ltd, Orchid Hlthcare, Epic Pharma Llc, Watson Labs Inc, Glenmark Generics, Sandoz Inc, Wockhardt, West-ward Pharms Int, G And W Labs Inc, Mylan Pharms Inc, Apotex, Actavis Elizabeth, Dr Reddys Labs Ltd, Mylan, Alembic Pharms Ltd, and Wockhardt Ltd, and is included in nineteen NDAs. It is available from thirty-one 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-three suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

Summary for NDA: 078881

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078881

Mechanism of ActionDopamine Agonists

Suppliers and Packaging for NDA: 078881

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride
TABLET;ORAL 078881 ANDA Mylan Pharmaceuticals Inc. 0378-5501 0378-5501-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-5501-01)
ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride
TABLET;ORAL 078881 ANDA Mylan Pharmaceuticals Inc. 0378-5502 0378-5502-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-5502-01)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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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 verifification 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.

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