DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 090135
The generic ingredient in ROPINIROLE HYDROCHLORIDE is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-seven 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 | 35356-623-90 |
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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