Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200824
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 200MG 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
10/18/2011 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
09/18/2018 SUPPL-17 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-16 REMS - MODIFIED - D-N-A

Label is not available on this site.

09/30/2016 SUPPL-14 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/20/2016 SUPPL-13 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-12 REMS-Proposal

Label is not available on this site.

08/19/2014 SUPPL-8 REMS-Modified

Label is not available on this site.

06/25/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/15/2013 SUPPL-4 REMS-Modified

Label is not available on this site.

07/09/2012 SUPPL-3 REMS-Modified

Label is not available on this site.

07/09/2012 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

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