Details for New Drug Application (NDA): 079165
✉ Email this page to a colleague
The generic ingredient in ROPINIROLE HYDROCHLORIDE is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 079165
Tradename: | ROPINIROLE HYDROCHLORIDE |
Applicant: | Mlv |
Ingredient: | ropinirole hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 079165
Mechanism of Action | Dopamine Agonists |
Suppliers and Packaging for NDA: 079165
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 079165 | ANDA | Marlex Pharmaceuticals Inc | 10135-673 | 10135-673-01 | 100 TABLET, FILM COATED in 1 BOTTLE (10135-673-01) |
ROPINIROLE HYDROCHLORIDE | ropinirole hydrochloride | TABLET;ORAL | 079165 | ANDA | Marlex Pharmaceuticals Inc | 10135-674 | 10135-674-01 | 100 TABLET, FILM COATED in 1 BOTTLE (10135-674-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.25MG BASE | ||||
Approval Date: | Feb 7, 2012 | 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 7, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Feb 7, 2012 | TE: | AB | RLD: | No |
Complete Access Available with Subscription