DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 090135
NDA 090135 describes ROPINIROLE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz Inc, Watson Labs Inc, Wockhardt Ltd, Accord Hlthcare, Alembic Ltd, Apotex, Epic Pharma Llc, G And W Labs Inc, Glenmark Generics, Mylan, Orchid Hlthcare, Prinston Inc, West-ward Pharms Int, Wockhardt, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from twenty-nine 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 suppliers are listed for this compound. 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 suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 090135
| Tradename: | ROPINIROLE HYDROCHLORIDE |
| Applicant: | Glenmark Generics |
| Ingredient: | ropinirole hydrochloride |
| Patents: | 0 |
| Therapeutic Class: | Antiparkinson Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090135
| Mechanism of Action | Dopamine Agonists |
Suppliers and Packaging for NDA: 090135
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 090135 | ANDA | Lake Erie Medical DBA Quality Care Products LLC | 35356-623 | N | 35356-623-30 |
| ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 090135 | ANDA | Lake Erie Medical DBA Quality Care Products LLC | 35356-623 | N | 35356-623-60 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.25MG BASE | ||||
| Approval Date: | Feb 25, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Feb 25, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Feb 25, 2010 | TE: | AB | RLD: | No | ||||
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