Home Applications 078446 Application 078446
Type ANDA
Sponsor ICU MEDICAL INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 149MG/100ML;450MG/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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078446-001 AP
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 2 · 44 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 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078446-001 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 149MG/100ML;450MG/100ML INJECTABLE / INJECTION AP 2008-09-10 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0409-9257 Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE Hospira, Inc. ANDA Current 0409-9257 Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE Hospira, Inc. ANDA Current 0409-9257 Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE Hospira, Inc. ANDA Current 0990-9257 Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE ICU Medical Inc. ANDA Current 0990-9257 Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE ICU Medical Inc. ANDA Current 0990-9257 Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE ICU Medical Inc. ANDA Current 0990-9257 Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE ICU Medical Inc. ANDA Current