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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077852
Company: HIKMA
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
03/26/2021 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/26/2021 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

10/19/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/07/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

08/15/2011 SUPPL-4 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

11/17/2009 SUPPL-3 Labeling

Label is not available on this site.

05/21/2008 SUPPL-2 Labeling

Label is not available on this site.

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