FDA.reportPublic FDA data

Application 018519

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRRIGATING SOLUTION G IN PLASTIC CONTAINERCITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATESOLUTION;IRRIGATION3.24GM/100ML;380MG/100ML;430MG/100MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018519-001IRRIGATING SOLUTION G IN PLASTIC CONTAINERCITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE3.24GM/100ML;380MG/100ML;430MG/100MLSOLUTION / IRRIGATION1982-06-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N018519-001IRRIGATING SOLUTION G IN PLASTIC CONTAINER3.24GM/100ML;380MG/100ML;430MG/100MLSOLUTION / IRRIGATION1982-06-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018519-001IRRIGATING SOLUTION G IN PLASTIC CONTAINER3.24GM/100ML;380MG/100ML;430MG/100MLSOLUTION / IRRIGATION1982-06-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018519-001IRRIGATING SOLUTION G IN PLASTIC CONTAINER3.24GM/100ML;380MG/100ML;430MG/100MLSOLUTION / IRRIGATION1982-06-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018519-001IRRIGATING SOLUTION G IN PLASTIC CONTAINER3.24GM/100ML;380MG/100ML;430MG/100MLSOLUTION / IRRIGATION1982-06-22a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
15024SUPPL2002-07-17