Application 200656

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PERIKABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	EMULSION;INTRAVENOUS	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)	Yes	No
002	PERIKABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	EMULSION;INTRAVENOUS	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)	Yes	No
003	PERIKABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	EMULSION;INTRAVENOUS	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)	Yes	Yes
004	KABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	EMULSION;INTRAVENOUS	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)	Yes	No
005	KABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	EMULSION;INTRAVENOUS	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)	Yes	No
006	KABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	EMULSION;INTRAVENOUS	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)	Yes	No
007	KABIVEN IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL	EMULSION;INTRAVENOUS	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N200656-001	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	RLD, RS	2014-08-25
N200656-002	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	RLD, RS	2014-08-25
N200656-003	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	RLD, RS	2014-08-25
N200656-004	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	RLD, RS	2014-08-25
N200656-005	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	RLD, RS	2014-08-25
N200656-006	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	RLD, RS	2014-08-25
N200656-007	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	RLD, RS	2014-08-25

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N200656-001	12390398	2036-05-03	Drug product	2025-09-11
N200656-002	12390398	2036-05-03	Drug product	2025-09-11
N200656-003	12390398	2036-05-03	Drug product	2025-09-11
N200656-004	12390398	2036-05-03	Drug product	2025-09-11
N200656-005	12390398	2036-05-03	Drug product	2025-09-11
N200656-006	12390398	2036-05-03	Drug product	2025-09-11
N200656-007	12390398	2036-05-03	Drug product	2025-09-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N200656-001	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200656-002	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200656-003	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200656-004	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200656-005	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200656-006	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200656-007	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200656-001	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200656-002	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200656-003	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200656-004	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200656-005	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200656-006	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200656-007	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200656-001	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200656-002	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200656-003	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200656-004	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200656-005	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200656-006	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200656-007	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-001	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-002	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-003	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-004	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-005	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-006	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-007	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200656-001	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)	EMULSION / INTRAVENOUS	RLD	2014-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200656-002	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)	EMULSION / INTRAVENOUS	RLD	2014-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200656-003	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200656-004	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)	EMULSION / INTRAVENOUS	RLD	2014-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200656-005	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)	EMULSION / INTRAVENOUS	RLD	2014-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200656-006	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)	EMULSION / INTRAVENOUS	RLD	2014-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200656-007	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200656-001	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)	EMULSION / INTRAVENOUS	RLD	2014-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200656-002	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)	EMULSION / INTRAVENOUS	RLD	2014-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200656-003	PERIKABIVEN IN PLASTIC CONTAINER	2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)	EMULSION / INTRAVENOUS	RLD, RS	2014-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200656-004	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)	EMULSION / INTRAVENOUS	RLD	2014-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200656-005	KABIVEN IN PLASTIC CONTAINER	3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)	EMULSION / INTRAVENOUS	RLD	2014-08-25	`fd3edfee7708…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N200656-001	12390398	2036-05-03	Drug product	2025-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200656-002	12390398	2036-05-03	Drug product	2025-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200656-003	12390398	2036-05-03	Drug product	2025-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200656-004	12390398	2036-05-03	Drug product	2025-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200656-005	12390398	2036-05-03	Drug product	2025-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200656-006	12390398	2036-05-03	Drug product	2025-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200656-007	12390398	2036-05-03	Drug product	2025-09-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200656-001	12390398	2036-05-03	Drug product	2025-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200656-002	12390398	2036-05-03	Drug product	2025-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200656-003	12390398	2036-05-03	Drug product	2025-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200656-004	12390398	2036-05-03	Drug product	2025-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200656-005	12390398	2036-05-03	Drug product	2025-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200656-006	12390398	2036-05-03	Drug product	2025-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200656-007	12390398	2036-05-03	Drug product	2025-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200656-001	12390398	2036-05-03	Drug product	2025-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200656-002	12390398	2036-05-03	Drug product	2025-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200656-003	12390398	2036-05-03	Drug product	2025-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200656-004	12390398	2036-05-03	Drug product	2025-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200656-005	12390398	2036-05-03	Drug product	2025-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200656-006	12390398	2036-05-03	Drug product	2025-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200656-007	12390398	2036-05-03	Drug product	2025-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-001	12390398	2036-05-03	Drug product	2025-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-002	12390398	2036-05-03	Drug product	2025-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-003	12390398	2036-05-03	Drug product	2025-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-004	12390398	2036-05-03	Drug product	2025-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-005	12390398	2036-05-03	Drug product	2025-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-006	12390398	2036-05-03	Drug product	2025-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200656-007	12390398	2036-05-03	Drug product	2025-09-11	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200656-001	12390398	2036-05-03	Drug product	2025-09-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200656-002	12390398	2036-05-03	Drug product	2025-09-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200656-003	12390398	2036-05-03	Drug product	2025-09-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200656-004	12390398	2036-05-03	Drug product	2025-09-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200656-005	12390398	2036-05-03	Drug product	2025-09-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200656-006	12390398	2036-05-03	Drug product	2025-09-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200656-007	12390398	2036-05-03	Drug product	2025-09-11	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perikabiven	DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE	Fresenius Kabi USA, LLC	c2eb5522-8572-45f4-869d-42f9fd251bb6	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200656 application number: NDA200656 ndc (product): 63323-714
Kabiven	DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE	Fresenius Kabi USA, LLC	afeb4837-a759-4484-a76e-e04611c459e7	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200656 application number: NDA200656 ndc (product): 63323-712

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-712	Kabiven	Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine	Fresenius Kabi USA, LLC	NDA	Current
63323-712	Kabiven	Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine	Fresenius Kabi USA, LLC	NDA	Current
63323-714	Perikabiven	Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine	Fresenius Kabi USA, LLC	NDA	Current
63323-714	Perikabiven	Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82947	SUPPL	2025-07-28
82928	SUPPL	2025-07-25
74297	SUPPL	2023-05-18
74279	SUPPL	2023-05-18
71481	SUPPL	2022-06-30
71478	SUPPL	2022-06-29
9838	SUPPL	2016-04-14
40037	SUPPL	2016-04-13
43352	ORIG	2016-03-02
32044	ORIG	2014-08-27
18972	ORIG	2014-08-26