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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079040
Company: ACTAVIS ELIZABETH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None No No
MORPHINE SULFATE MORPHINE SULFATE 45MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None No No
MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None No No
MORPHINE SULFATE MORPHINE SULFATE 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None No No
MORPHINE SULFATE MORPHINE SULFATE 90MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None No No
MORPHINE SULFATE MORPHINE SULFATE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/16/2013 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/079040Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2025 SUPPL-37 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/11/2025 SUPPL-32 Labeling-Package Insert

Label is not available on this site.
10/31/2024 SUPPL-30 REMS - MODIFIED - D-N-A

Label is not available on this site.
10/01/2025 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/15/2023 SUPPL-27 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/15/2023 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/04/2023 SUPPL-24 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
03/04/2021 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/11/2019 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
02/02/2021 SUPPL-20 Labeling-Package Insert

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

Label is not available on this site.
05/26/2017 SUPPL-17 REMS-Modified

Label is not available on this site.
03/11/2021 SUPPL-15 Labeling-Package Insert

Label is not available on this site.
09/30/2016 SUPPL-14 REMS - MODIFIED - D-N-A

Label is not available on this site.
03/11/2021 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
04/20/2016 SUPPL-11 REMS-Modified

Label is not available on this site.
06/26/2015 SUPPL-10 REMS-Modified

Label is not available on this site.
08/19/2014 SUPPL-7 REMS-Modified

Label is not available on this site.
07/03/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
07/02/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
04/15/2013 SUPPL-3 REMS-Modified

Label is not available on this site.
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