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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074769
Company: RHODES PHARMS
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
07/02/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74769ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74769ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74769.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-29 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-28 REMS-Modified

Label is not available on this site.

09/30/2016 SUPPL-27 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/20/2016 SUPPL-24 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-22 REMS-Proposal

Label is not available on this site.

08/19/2014 SUPPL-20 REMS-Modified

Label is not available on this site.

07/21/2014 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/15/2013 SUPPL-13 REMS-Modified

Label is not available on this site.

09/28/2012 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/09/2012 SUPPL-10 REMS-Proposal

Label is not available on this site.

07/11/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

07/11/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

07/11/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

07/11/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

07/11/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

07/11/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/02/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74769ap_appltr_prntlbl_chemr.pdf

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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