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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 200656

CSV Excel Print

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

Showing 1 to 7 of 7 entries

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

Original Approvals or Tentative Approvals

CSV Excel Print

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
08/25/2014	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review	Label includes KABIVEN and PERIKABIVEN

Showing 1 to 1 of 1 entries

Supplements

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
05/17/2023	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)
06/28/2022	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)
06/09/2016	SUPPL-3	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
04/11/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Showing 1 to 5 of 5 entries

Labels for NDA 200656

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
05/17/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)
06/28/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)
04/12/2016	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)	Label includes KABIVEN and PERIKABIVEN
04/12/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)	Label includes KABIVEN and PERIKABIVEN
08/25/2014	ORIG-1	Approval	Label (PDF)	Label includes KABIVEN and PERIKABIVEN

Showing 1 to 5 of 5 entries

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