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 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 UTC2022-10A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13e64feba35796…
2022-09-29 23:25 UTC2022-09A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13e64feba35796…
2022-09-29 23:25 UTC2022-09A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13e64feba35796…
2022-09-29 23:25 UTC2022-09A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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