FDA.reportPublic FDA data

Application 017637

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002PHYSIOSOL IN PLASTIC CONTAINERMAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATESOLUTION;IRRIGATION30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/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
N017637-002PHYSIOSOL IN PLASTIC CONTAINERMAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08

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 UTC2022-10N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08a50c72e98297…

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-6141PhysiosolSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDEHospira, Inc.NDACurrent
0990-6141PhysiosolSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDEICU Medical Inc.NDACurrent
0990-6141PhysiosolSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDEICU Medical Inc.NDACurrent
0990-6141PhysiosolSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDEICU Medical Inc.NDACurrent
0990-6141PhysiosolSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDEICU Medical Inc.NDACurrent