Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022195
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription AA Yes No
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription AA Yes No
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription AA Yes 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
03/17/2008 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022195,022207lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022195s000, 022207s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195_022207_morphine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195s000_022207s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/22/2021 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022195Orig1s020ltr.pdf
03/04/2021 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022195Orig1s019ltr.pdf
10/07/2019 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022195s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022195Orig1s018ltr.pdf
09/18/2018 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022195s014s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022195Orig1s014s016ltr.pdf
09/18/2018 SUPPL-14 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022195s014s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022195Orig1s014s016ltr.pdf
12/16/2016 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022195s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022195Orig1s011ltr.pdf
06/02/2021 SUPPL-10 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022195Orig1s010, 022207Orig1s005ltr.pdf
01/09/2014 SUPPL-9 Labeling-Medication Guide Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022195Orig1s009ltr.pdf
04/18/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/21/2015 SUPPL-7 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022195s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022195Orig1s007ltr.pdf
01/23/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022195s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022195s006ltr.pdf
10/18/2011 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022195s005ltr.pdf
06/10/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/25/2010 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022195s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022195s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/22/2021 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s020lbl.pdf
06/02/2021 SUPPL-10 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s010lbl.pdf
03/04/2021 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s019lbl.pdf
10/07/2019 SUPPL-18 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022195s018lbl.pdf
10/07/2019 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022195s018lbl.pdf
09/18/2018 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022195s014s016lbl.pdf
09/18/2018 SUPPL-14 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022195s014s016lbl.pdf
12/16/2016 SUPPL-11 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022195s011lbl.pdf
12/16/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022195s011lbl.pdf
12/16/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022195s011lbl.pdf
04/21/2015 SUPPL-7 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022195s007lbl.pdf
01/23/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022195s006lbl.pdf
01/25/2010 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022195s002lbl.pdf
03/17/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022195,022207lbl.pdf

MORPHINE SULFATE

SOLUTION;ORAL; 10MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription Yes AA 022195 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription No AA 206308 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION;ORAL Prescription No AA 203518 TRIS PHARMA INC

SOLUTION;ORAL; 20MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription Yes AA 022195 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription No AA 206420 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 20MG/5ML SOLUTION;ORAL Prescription No AA 203519 TRIS PHARMA INC

SOLUTION;ORAL; 100MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 208809 AKORN
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription Yes AA 022195 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 201574 PADAGIS US
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 206573 PHARM ASSOC
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 206308 RHODES PHARMS
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 202348 SPECGX LLC
MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION;ORAL Prescription No AA 203518 TRIS PHARMA INC

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