Drugs@FDA: FDA Approved Drug Products

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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
10/11/2019 SUPPL-21 Labeling-Medication Guide, 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.

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

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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