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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202718
Company: TEVA PHARMS USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 40MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 70MG CAPSULE, 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
12/29/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202718Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2023 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/15/2023 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/04/2023 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-7 REMS - MODIFIED - D-N-A

Label is not available on this site.
12/04/2023 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
05/26/2017 SUPPL-5 REMS-Modified

Label is not available on this site.
09/30/2016 SUPPL-4 REMS - MODIFIED - D-N-A

Label is not available on this site.
04/20/2016 SUPPL-3 REMS-Modified

Label is not available on this site.
06/26/2015 SUPPL-2 REMS-Modified

Label is not available on this site.
06/03/2015 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.
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