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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075295
Company: STRIDES PHARMA INTL

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
10/28/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75295ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/075295.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2024 SUPPL-57 REMS - MODIFIED - D-N-A

Label is not available on this site.
09/18/2018 SUPPL-51 REMS - MODIFIED - D-N-A

Label is not available on this site.
05/26/2017 SUPPL-48 REMS-Modified

Label is not available on this site.
09/30/2016 SUPPL-47 REMS - MODIFIED - D-N-A

Label is not available on this site.
04/20/2016 SUPPL-44 REMS-Modified

Label is not available on this site.
06/26/2015 SUPPL-41 REMS-Modified

Label is not available on this site.
08/19/2014 SUPPL-38 REMS-Modified

Label is not available on this site.
08/11/2014 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/28/2013 SUPPL-32 REMS-Modified

Label is not available on this site.
07/09/2012 SUPPL-30 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
07/09/2012 SUPPL-28 REMS-Proposal

Label is not available on this site.
12/20/2010 SUPPL-26 Labeling

Label is not available on this site.
07/02/2010 SUPPL-24 Labeling-Package Insert

Label is not available on this site.
11/06/2002 SUPPL-14 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
11/06/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
11/26/2001 SUPPL-12 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
08/15/2001 SUPPL-11 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
01/25/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
09/15/2000 SUPPL-9 Labeling

Label is not available on this site.
09/15/2000 SUPPL-8 Manufacturing (CMC)-New Strength

Label is not available on this site.
09/15/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.
09/15/2000 SUPPL-6 Labeling

Label is not available on this site.
09/15/2000 SUPPL-5 Manufacturing (CMC)-New Strength

Label is not available on this site.
11/03/1999 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
08/12/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
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