Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019916
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 1MG/ML INJECTABLE;INJECTION Discontinued None Yes No
MORPHINE SULFATE MORPHINE SULFATE 5MG/ML INJECTABLE;INJECTION Discontinued None Yes 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
10/30/1992 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019916s019,019917s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019916Orig1s019, 019917Orig1s012ltr.pdf
12/16/2016 SUPPL-17 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019916s016s017,019917s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019916Orig1s16,s017;019917Orig1s010,s011ltr.pdf
12/16/2016 SUPPL-16 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019916s016s017,019917s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019916Orig1s16,s017;019917Orig1s010,s011ltr.pdf
03/09/2016 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/18/2008 SUPPL-10 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

10/27/2006 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019916s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019916s004ltr.pdf
01/19/1996 SUPPL-1 Manufacturing (CMC)-Control

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-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019916s019,019917s012lbl.pdf
12/16/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019916s016s017,019917s010s011lbl.pdf
12/16/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019916s016s017,019917s010s011lbl.pdf
12/16/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019916s016s017,019917s010s011lbl.pdf
12/16/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019916s016s017,019917s010s011lbl.pdf
10/27/2006 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019916s004lbl.pdf
10/27/2006 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019916s004lbl.pdf

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