Details for New Drug Application (NDA): 200462
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The generic ingredient in ROPINIROLE HYDROCHLORIDE is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 200462
Tradename: | ROPINIROLE HYDROCHLORIDE |
Applicant: | Mylan Pharms Inc |
Ingredient: | ropinirole hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Oct 15, 2012 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 3MG BASE | ||||
Approval Date: | Oct 15, 2012 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Oct 15, 2012 | TE: | RLD: | No |
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