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 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13c2088c7a36db…
2026-10-15 13:18:302026-09A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13c2088c7a36db…
2026-10-15 13:18:302026-09A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13c2088c7a36db…
2026-10-15 13:18:302026-09A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13c2088c7a36db…
2026-09-14 22:38:342026-08A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1384e616aacf4f…
2026-09-14 22:38:342026-08A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1384e616aacf4f…
2026-09-14 22:38:342026-08A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1384e616aacf4f…
2026-09-14 22:38:342026-08A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1384e616aacf4f…
2026-08-18 06:07:402026-07A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A020374-001INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A020374-002INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A020374-003INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A020374-004INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1994-06-132680178bc6a6…

Reported adverse events (FAERS/openFDA)#

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