Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204223
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 2MG/ML (2MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription None Yes Yes
MORPHINE SULFATE MORPHINE SULFATE 4MG/ML (4MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription None Yes Yes
MORPHINE SULFATE MORPHINE SULFATE 5MG/ML (5MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription None Yes Yes
MORPHINE SULFATE MORPHINE SULFATE 8MG/ML (8MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription None Yes Yes
MORPHINE SULFATE MORPHINE SULFATE 10MG/ML (10MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription None 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
10/30/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204223s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204223Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204223Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204223Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204223s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204223Orig1s015ltr.pdf
01/27/2017 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

12/16/2016 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204223s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204223Orig1s006ltr.pdf
03/03/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/16/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/23/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204223s015lbl.pdf
12/16/2016 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204223s006lbl.pdf
12/16/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204223s006lbl.pdf
12/16/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204223s006lbl.pdf
10/30/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204223s000lbl.pdf

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