FDA.reportPublic FDA data

Application 018460

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDESOLUTION;INTRAPERITONEAL29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLNoNo
002DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100MLNoNo
003DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDESOLUTION;INTRAPERITONEAL29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLNoNo
004DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100MLNoNo
005DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLNoNo
006DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDESOLUTION;INTRAPERITONEAL29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLNoNo
007DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLNoNo
008DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLNoNo
009DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATESOLUTION;INTRAPERITONEAL26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018460-001DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982
N018460-002DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982
N018460-003DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982
N018460-004DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982
N018460-005DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1983-11-02
N018460-006DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEAL1986-01-29
N018460-007DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-29
N018460-008DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-29
N018460-009DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-29

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 2 of 10 · 396 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018460-005DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1983-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018460-006DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEAL1986-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018460-007DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018460-008DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018460-009DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N018460-001DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018460-002DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100MLSOLUTION / INTRAPERITONEALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018460-003DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018460-004DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100MLSOLUTION / INTRAPERITONEALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018460-005DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1983-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018460-006DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEAL1986-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018460-007DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018460-008DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018460-009DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018460-001DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018460-002DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018460-003DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018460-004DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018460-005DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1983-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018460-006DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEAL1986-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018460-007DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018460-008DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018460-009DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018460-001DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018460-002DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018460-003DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018460-004DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100MLSOLUTION / INTRAPERITONEALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018460-005DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1983-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018460-006DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEAL1986-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018460-007DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018460-008DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018460-009DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018460-001DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018460-002DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100MLSOLUTION / INTRAPERITONEALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018460-003DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018460-004DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100MLSOLUTION / INTRAPERITONEALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018460-005DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1983-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018460-006DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100MLSOLUTION / INTRAPERITONEAL1986-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018460-007DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018460-008DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100MLSOLUTION / INTRAPERITONEAL1986-01-2903ed91905a0d…

Reported adverse events (FAERS/openFDA)#

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