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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26782e0a99824c…
2021-12-28 21:50 UTC2021-12N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26782e0a99824c…
2021-12-28 21:50 UTC2021-12N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26782e0a99824c…
2021-12-28 21:50 UTC2021-12N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-2687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-2687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-2687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-265aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-265aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-265aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-268869cabd3fbd…
2020-12-22 03:56 UTC2020-12N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-268869cabd3fbd…
2020-12-22 03:56 UTC2020-12N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-268869cabd3fbd…
2020-12-22 03:56 UTC2020-12N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26c0c555d07b60…
2020-11-12 02:37 UTC2020-11N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26c0c555d07b60…
2020-11-12 02:37 UTC2020-11N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26c0c555d07b60…
2020-11-12 02:37 UTC2020-11N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-263f01610625f2…
2019-12-14 00:12 UTC2019-12N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-263f01610625f2…
2019-12-14 00:12 UTC2019-12N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-263f01610625f2…
2019-12-14 00:12 UTC2019-12N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-263f01610625f2…
2019-09-15 20:21 UTC2019-09N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26b00525d2431f…
2019-09-15 20:21 UTC2019-09N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26b00525d2431f…
2019-09-15 20:21 UTC2019-09N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26b00525d2431f…
2019-09-15 20:21 UTC2019-09N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N018807-001DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26ea99ee380514…
2019-07-19 19:46 UTC2019-07N018807-002DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26ea99ee380514…
2019-07-19 19:46 UTC2019-07N018807-003DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26ea99ee380514…
2019-07-19 19:46 UTC2019-07N018807-004DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100MLSOLUTION / INTRAPERITONEAL1983-08-26ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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