Home Applications 018722 Application 018722
Type NDA
Sponsor B BRAUN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 75MG/100ML;900MG/100ML No No 002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;900MG/100ML No No 003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 220MG/100ML;900MG/100ML No No 004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 300MG/100ML;900MG/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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09
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 3 of 5 · 176 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 2019-12-13 00:20 UTC 2019-12 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.