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 4 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
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`

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)#