Drugs@FDA: FDA Approved Drug Products

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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 Prescription AP Yes Yes
MORPHINE SULFATE MORPHINE SULFATE 5MG/ML INJECTABLE;INJECTION 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
10/30/1992 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
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-Container/Carton Labels, Labeling-Package Insert

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
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

MORPHINE SULFATE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAMORPH PF MORPHINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription Yes AP 018565 WEST-WARD PHARMS INT
MORPHINE SULFATE MORPHINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 071850 HOSPIRA
MORPHINE SULFATE MORPHINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 073510 HOSPIRA
MORPHINE SULFATE MORPHINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription Yes AP 019916 ICU MEDICAL INC

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