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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019916
Company: ICU MEDICAL INC

Products on NDA 019916

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
MORPHINE SULFATE	MORPHINE SULFATE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019916

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.

Labels for NDA 019916

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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