Application 018460

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	SOLUTION;INTRAPERITONEAL	29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	No	No
002	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	No	No
003	DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	SOLUTION;INTRAPERITONEAL	29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	No	No
004	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	No	No
005	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	No	No
006	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	SOLUTION;INTRAPERITONEAL	29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	No	No
007	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	No	No
008	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	No	No
009	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;INTRAPERITONEAL	26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/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 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018460-001	DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982
N018460-002	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982
N018460-003	DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982
N018460-004	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982
N018460-005	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1983-11-02
N018460-006	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE	29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29
N018460-007	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29
N018460-008	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29
N018460-009	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29

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 10 · 396 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N018460-001	DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018460-002	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018460-003	DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018460-004	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018460-005	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1983-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018460-006	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018460-007	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018460-008	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018460-009	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018460-001	DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018460-002	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018460-003	DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018460-004	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018460-005	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1983-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018460-006	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018460-007	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018460-008	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018460-009	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018460-001	DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018460-002	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018460-003	DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018460-004	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018460-005	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1983-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018460-006	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018460-007	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018460-008	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018460-009	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018460-001	DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018460-002	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018460-003	DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018460-004	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018460-005	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1983-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018460-006	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018460-007	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018460-008	DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER	26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018460-009	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML	SOLUTION / INTRAPERITONEAL		1986-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018460-001	DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018460-002	DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER	26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018460-003	DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018460-004	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML	SOLUTION / INTRAPERITONEAL	Approved before 1982		`31067a03dcf5…`

Reported adverse events (FAERS/openFDA)#

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

Application 018460

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#