Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204223
Company: FRESENIUS KABI USA
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 |
---|---|---|---|---|---|
12/15/2023 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204223s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204223Orig1s025ltr.pdf | |
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-Container/Carton Labels, Labeling-Package Insert |
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 |
---|---|---|---|---|---|
12/15/2023 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204223s025lbl.pdf | |
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 |