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Abbreviated New Drug Application (ANDA): 203849
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
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
04/06/2015 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203849Orig1s000MG.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203849Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-15 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-11 REMS-Modified

Label is not available on this site.

09/30/2016 SUPPL-7 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/20/2016 SUPPL-4 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-1 REMS-Modified

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/06/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203849Orig1s000MG.pdf

MORPHINE SULFATE

TABLET, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203849 ACTAVIS ELIZABETH
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075407 DAVA PHARMS INC
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205386 MAYNE PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203602 NOVEL LABS INC
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 074862 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076412 SPECGX LLC
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075295 STRIDES PHARMA
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078761 SUN PHARM INDS LTD
MS CONTIN MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019516 PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203849 ACTAVIS ELIZABETH
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205386 MAYNE PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203602 NOVEL LABS INC
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 074862 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076412 SPECGX LLC
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075295 STRIDES PHARMA
MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078761 SUN PHARM INDS LTD
MS CONTIN MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019516 PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203849 ACTAVIS ELIZABETH
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205386 MAYNE PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203602 NOVEL LABS INC
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 074862 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076412 SPECGX LLC
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075295 STRIDES PHARMA
MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078761 SUN PHARM INDS LTD
MS CONTIN MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019516 PURDUE PHARMA LP

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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