Home Applications 018030 Application 018030
Type NDA
Sponsor B BRAUN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;450MG/100ML No No 002 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;450MG/100ML No No 003 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;330MG/100ML No No 004 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;200MG/100ML No No 005 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;110MG/100ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018030-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 N018030-002 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 N018030-003 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;330MG/100ML INJECTABLE / INJECTION Approved before 1982 N018030-004 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;200MG/100ML INJECTABLE / INJECTION Approved before 1982 N018030-005 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;110MG/100ML INJECTABLE / INJECTION Approved before 1982
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 4 of 6 · 220 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2021-03-12 10:30 UTC 2021-03 N018030-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N018030-002 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N018030-003 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N018030-004 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N018030-005 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018030-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N018030-002 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N018030-003 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N018030-004 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N018030-005 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018030-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N018030-002 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N018030-003 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N018030-004 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N018030-005 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018030-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N018030-002 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N018030-003 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N018030-004 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N018030-005 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018030-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N018030-002 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N018030-003 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N018030-004 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N018030-005 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018030-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N018030-002 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N018030-003 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N018030-004 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N018030-005 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018030-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018030-002 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018030-003 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018030-004 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018030-005 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018030-001 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 2.5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N018030-002 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5GM/100ML;450MG/100ML INJECTABLE / INJECTION Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N018030-003 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER 5GM/100ML;330MG/100ML INJECTABLE / INJECTION Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N018030-004 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER 5GM/100ML;200MG/100ML INJECTABLE / INJECTION Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N018030-005 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER 5GM/100ML;110MG/100ML INJECTABLE / INJECTION Approved before 1982 1c564ffb4f44…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.