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Details for New Drug Application (NDA): 077852

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NDA 077852 describes ROPINIROLE HYDROCHLORIDE, which is a drug marketed by Prinston Inc, Zydus Pharms Usa Inc, Alembic Ltd, Orchid Hlthcare, Corepharma, 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, and Wockhardt Ltd, and is included in eighteen NDAs. It is available from thirty-three 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-five suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

Summary for NDA: 077852

Tradename:
ROPINIROLE HYDROCHLORIDE
Applicant:
West-ward Pharms Int
Ingredient:
ropinirole hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077852

Mechanism of ActionDopamine Agonists

Suppliers and Packaging for NDA: 077852

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride
TABLET;ORAL 077852 ANDA Roxane Laboratories, Inc 0054-0116 0054-0116-25 100 TABLET in 1 BOTTLE (0054-0116-25)
ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride
TABLET;ORAL 077852 ANDA Roxane Laboratories, Inc 0054-0117 0054-0117-25 100 TABLET in 1 BOTTLE (0054-0117-25)

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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