Application 019634

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATEINJECTABLE;INJECTION10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLNoNo
002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATEINJECTABLE;INJECTION4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLNoNo
003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATEINJECTABLE;INJECTION20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-24
N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-24
N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N019634-003AP

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-24caaa826d4ba7…
2026-08-18 06:07:402026-07N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-24caaa826d4ba7…
2026-08-18 06:07:402026-07N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019634-002DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100MLINJECTABLE / INJECTION1988-02-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019634-003DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1988-02-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019634-001DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100MLINJECTABLE / INJECTION1988-02-241e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019634-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019634-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019634-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019634-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019634-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019634-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019634-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019634-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019634-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019634-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019634-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019634-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019634-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019634-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019634-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019634-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019634-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019634-003AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019634-003AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019634-003AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019634-003AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019634-003AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N019634-003AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019634-003AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019634-003AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019634-003AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N019634-003AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019634-003AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019634-003AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019634-003AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019634-003AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019634-003AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019634-003AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019634-003AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019634-003AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019634-003AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019634-003AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019634-003AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019634-003AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019634-003AP1e64feba35796…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.190da07e-a616-46e6-b4e5-1c0ba39306e52025-11-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 019634
application number: NDA019634
ndc (product): 0264-7751

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-7751Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7751Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7751Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7751Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84113SUPPL 2025-11-06
84081SUPPL 2025-11-06
69252SUPPL2021-11-05
69225SUPPL2021-11-04
1427SUPPL2013-02-15
33818SUPPL2013-02-14
17495SUPPL2004-10-04
11573SUPPL2004-10-04