FDA.reportPublic FDA data

Application 018379

Type
NDA
Sponsor
FRESENIUS MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLNoNo
002DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLNoNo
003DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLNoNo
004DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLNoNo
005DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLNoNo
006DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLNoNo
007DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLNoNo
008DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL25.7MG/100ML;3.5GM/100ML;5.08MG/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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018379-001DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982
N018379-002DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982
N018379-003DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982
N018379-004DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-07
N018379-005DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-07
N018379-006DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-07
N018379-007DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEAL1988-06-24
N018379-008DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1988-06-24

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 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018379-001DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018379-002DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018379-003DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018379-004DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018379-005DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018379-006DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018379-007DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEAL1988-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018379-008DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1988-06-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018379-001DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018379-002DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018379-003DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018379-004DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018379-005DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018379-006DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018379-007DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEAL1988-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018379-008DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1988-06-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N018379-001DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018379-002DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018379-003DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018379-004DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018379-005DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018379-006DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018379-007DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEAL1988-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018379-008DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1988-06-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018379-001DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018379-002DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018379-003DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018379-004DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018379-005DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018379-006DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018379-007DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEAL1988-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018379-008DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1988-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018379-001DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018379-002DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018379-003DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018379-004DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018379-005DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018379-006DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1982-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018379-007DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100MLSOLUTION / INTRAPERITONEAL1988-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018379-008DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100MLSOLUTION / INTRAPERITONEAL1988-06-24b8a1b40f171c…