Application 018807

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	SOLUTION;INTRAPERITONEAL	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	No	No
002	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	SOLUTION;INTRAPERITONEAL	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	No	No
003	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	SOLUTION;INTRAPERITONEAL	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	No	No
004	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	SOLUTION;INTRAPERITONEAL	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N018807-001	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26
N018807-002	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26
N018807-003	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26
N018807-004	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26

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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N018807-001	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018807-002	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018807-003	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018807-004	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018807-001	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018807-002	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018807-003	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018807-004	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018807-001	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018807-002	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018807-003	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018807-004	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018807-001	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018807-002	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018807-003	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018807-004	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018807-001	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018807-002	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018807-003	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018807-004	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018807-001	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018807-002	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018807-003	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018807-004	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018807-001	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018807-002	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018807-003	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018807-004	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018807-001	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018807-002	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018807-003	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018807-004	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018807-001	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018807-002	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018807-003	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018807-004	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018807-001	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018807-002	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018807-003	DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER	510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018807-004	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML	SOLUTION / INTRAPERITONEAL	1983-08-26	`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

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

Application 018807

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#