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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076438
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
MORPHINE SULFATE MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
07/03/2003 ORIG-1 Approval

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-25 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-23 REMS-Modified

Label is not available on this site.

09/30/2016 SUPPL-22 REMS - MODIFIED - D-N-A

Label is not available on this site.

11/03/2016 SUPPL-21 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

04/20/2016 SUPPL-19 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-17 REMS-Modified

Label is not available on this site.

05/16/2015 SUPPL-16 Labeling-Container/Carton Labels

Label is not available on this site.

08/19/2014 SUPPL-15 REMS-Modified

Label is not available on this site.

06/25/2014 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/15/2013 SUPPL-12 REMS-Modified

Label is not available on this site.

07/09/2012 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

07/09/2012 SUPPL-10 REMS-Proposal

Label is not available on this site.

08/13/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

07/22/2009 SUPPL-7 Labeling

Label is not available on this site.

09/30/2004 SUPPL-5 Labeling

Label is not available on this site.

11/06/2003 SUPPL-3 Labeling

Label is not available on this site.

03/19/2004 SUPPL-2 Labeling

Label is not available on this site.

MORPHINE SULFATE

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203849 ACTAVIS ELIZABETH
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205386 MAYNE PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203602 NOVEL LABS INC
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 074769 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076438 SPECGX LLC
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075295 STRIDES PHARMA
MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078761 SUN PHARM INDS LTD
MS CONTIN MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019516 PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203849 ACTAVIS ELIZABETH
MORPHINE SULFATE MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203602 NOVEL LABS INC
MORPHINE SULFATE MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 074769 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076438 SPECGX LLC
MORPHINE SULFATE MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075295 STRIDES PHARMA
MORPHINE SULFATE MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078761 SUN PHARM INDS LTD
MS CONTIN MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019516 PURDUE PHARMA LP
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