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Generated: April 28, 2017

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Details for New Drug Application (NDA): 200462

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NDA 200462 describes ROPINIROLE HYDROCHLORIDE, which is a drug marketed by Prinston Inc, Zydus Pharms Usa Inc, Accord Hlthcare 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 nineteen NDAs. It is available from thirty-two 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-four suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

Summary for NDA: 200462

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

Pharmacology for NDA: 200462

Mechanism of ActionDopamine Agonists

Suppliers and Packaging for NDA: 200462

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200462 ANDA Mylan Pharmaceuticals Inc. 0378-4090 0378-4090-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4090-93)
ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200462 ANDA Mylan Pharmaceuticals Inc. 0378-4091 0378-4091-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4091-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 2MG BASE
Approval Date:Oct 15, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 3MG BASE
Approval Date:Oct 15, 2012TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 4MG BASE
Approval Date:Oct 15, 2012TE:ABRLD:No


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