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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204223
Company: FRESENIUS KABI USA

Summary Review

Products on NDA 204223

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204223

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.

Labels for NDA 204223

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

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