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 5 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 2022-10-28 04:53 UTC 2022-10 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 e64feba35796…2022-09-29 23:25 UTC 2022-09 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 e64feba35796…2022-09-29 23:25 UTC 2022-09 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 e64feba35796…2022-09-29 23:25 UTC 2022-09 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018722-001 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 75MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018722-002 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 150MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018722-003 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER 220MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018722-004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 300MG/100ML;900MG/100ML INJECTABLE / INJECTION 1982-11-09 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.