FDA.reportPublic FDA data

Application 020374

Type
ANDA
Sponsor
FRESENIUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLNoNo
002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLNoNo
003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLNoNo
004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/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
A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13
A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13
A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13
A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13

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 UTC2019-12A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-135aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-135aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-135aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13c0c555d07b60…
2020-11-12 02:37 UTC2020-11A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13c0c555d07b60…
2020-11-12 02:37 UTC2020-11A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13c0c555d07b60…
2020-11-12 02:37 UTC2020-11A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-133f01610625f2…
2019-12-14 00:12 UTC2019-12A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-133f01610625f2…
2019-12-14 00:12 UTC2019-12A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-133f01610625f2…
2019-12-14 00:12 UTC2019-12A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-133f01610625f2…
2019-09-15 20:21 UTC2019-09A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13b00525d2431f…
2019-09-15 20:21 UTC2019-09A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13b00525d2431f…
2019-09-15 20:21 UTC2019-09A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13b00525d2431f…
2019-09-15 20:21 UTC2019-09A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13ea99ee380514…
2019-07-19 19:46 UTC2019-07A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13ea99ee380514…
2019-07-19 19:46 UTC2019-07A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13ea99ee380514…
2019-07-19 19:46 UTC2019-07A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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