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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078881
Company: MYLAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET;ORAL Discontinued None No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Discontinued None No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Discontinued None No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Discontinued None No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Discontinued None No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Discontinued None No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/05/2008 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2023 SUPPL-25 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
12/07/2020 SUPPL-22 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
03/03/2020 SUPPL-20 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
03/03/2020 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
10/19/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
02/22/2012 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
11/30/2009 SUPPL-4 Labeling-Patient Package Insert

Label is not available on this site.
05/19/2008 SUPPL-1 Labeling

Label is not available on this site.
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