An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 200656
Company: FRESENIUS KABI USA

Products on NDA 200656

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	No
KABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	No
KABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	No
KABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	Yes
PERIKABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	No
PERIKABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	No
PERIKABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200656

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/2014	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review	Label includes KABIVEN and PERIKABIVEN	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200656s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200656Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/200656Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2023	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200656s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/200656Orig1s018ltr.pdf
06/28/2022	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/200656s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/200656Orig1s014ltr.pdf
06/09/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/11/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/12/2016	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)	Label includes KABIVEN and PERIKABIVEN	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200656s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200656Orig1s001ltr.pdf

Labels for NDA 200656

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200656s018lbl.pdf
06/28/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/200656s014lbl.pdf
04/12/2016	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)	Label includes KABIVEN and PERIKABIVEN	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200656s001lbl.pdf
04/12/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)	Label includes KABIVEN and PERIKABIVEN	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200656s001lbl.pdf
08/25/2014	ORIG-1	Approval	Label (PDF)	Label includes KABIVEN and PERIKABIVEN	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200656s000lbl.pdf

Top