FDA.reportPublic FDA data

Application 018807

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDESOLUTION;INTRAPERITONEAL510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLNoNo
002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDESOLUTION;INTRAPERITONEAL510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLNoNo
003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDESOLUTION;INTRAPERITONEAL510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLNoNo
004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDESOLUTION;INTRAPERITONEAL510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26
N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26
N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26
N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26

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 5 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26e64feba35796…
2022-09-29 23:25 UTC2022-09N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26e64feba35796…
2022-09-29 23:25 UTC2022-09N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26e64feba35796…
2022-09-29 23:25 UTC2022-09N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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