Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019916
Company: ICU MEDICAL INC
Company: ICU MEDICAL INC
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MORPHINE SULFATE | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
MORPHINE SULFATE | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
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 |