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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078230
Company: EPIC PHARMA LLC
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
05/20/2008 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
03/04/2020 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/04/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/04/2020 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

10/31/2011 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

04/28/2010 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

11/30/2009 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

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