Home Applications 019869 Application 019869
Type NDA
Sponsor ICU MEDICAL INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION LIQUID;N/A 100% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N019869-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID / N/A AP RLD, RS 1989-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019869-001 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 · 43 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 2022-09-29 23:25 UTC 2022-09 N019869-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1989-12-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019869-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1989-12-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019869-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1989-12-26 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0409-7118 Sterile Water WATER Hospira, Inc. NDA Current 0409-7118 Sterile Water WATER Hospira, Inc. NDA Current 0990-7118 Sterile Water WATER ICU Medical Inc. NDA Current 0990-7118 Sterile Water WATER ICU Medical Inc. NDA Current 0990-7118 Sterile Water WATER ICU Medical Inc. NDA Current