FDA.reportPublic FDA data

Application 019395

Type
NDA
Sponsor
FRESENIUS MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLNoNo
002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLNoNo
003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26
N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26
N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26

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 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019395-002INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019395-003INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019395-001INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1986-03-268072bd15b7f6…