Home Applications 018495 Application 018495
Type NDA
Sponsor BAXTER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE SOLUTION;IRRIGATION 33MG/100ML;30MG/100ML;860MG/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 N018495-001 RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33MG/100ML;30MG/100ML;860MG/100ML SOLUTION / IRRIGATION AT 1982-02-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018495-001 AT
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 N018495-001 RINGER'S IN PLASTIC CONTAINER 33MG/100ML;30MG/100ML;860MG/100ML SOLUTION / IRRIGATION AT 1982-02-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018495-001 RINGER'S IN PLASTIC CONTAINER 33MG/100ML;30MG/100ML;860MG/100ML SOLUTION / IRRIGATION AT 1982-02-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018495-001 RINGER'S IN PLASTIC CONTAINER 33MG/100ML;30MG/100ML;860MG/100ML SOLUTION / IRRIGATION AT 1982-02-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018495-001 RINGER'S IN PLASTIC CONTAINER 33MG/100ML;30MG/100ML;860MG/100ML SOLUTION / IRRIGATION AT 1982-02-19 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ringers SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, Baxter Healthcare Corporation e1953d54-818d-46a6-8532-518ebae6d84e 2012-06-13 Exact identifier application applno (NDA): 018495 application number: NDA018495 ndc (product): 0338-0104
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0338-0104 Ringers sodium chloride, calcium chloride, potassium chloride, Baxter Healthcare Corporation NDA Current 0338-0104 Ringers sodium chloride, calcium chloride, potassium chloride, Baxter Healthcare Corporation NDA Current 0338-0104 Ringers sodium chloride, calcium chloride, potassium chloride, Baxter Healthcare Corporation NDA Current 0338-0104 Ringers sodium chloride, calcium chloride, potassium chloride, Baxter Healthcare Corporation NDA Current 0338-0104 Ringers sodium chloride, calcium chloride, potassium chloride, Baxter Healthcare Corporation NDA Current 0338-0104 Ringers sodium chloride, calcium chloride, potassium chloride, Baxter Healthcare Corporation NDA Current