Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200462
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;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
10/15/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/16/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

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