FDA.reportPublic FDA data

Application 017385

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;32MG/100ML;128MG/100ML;234MG/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
N017385-001PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE5GM/100ML;32MG/100ML;128MG/100ML;234MG/100MLINJECTABLE / INJECTIONApproved before 1982

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 UTC2022-10N017385-001PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;32MG/100ML;128MG/100ML;234MG/100MLINJECTABLE / INJECTIONApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017385-001PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;32MG/100ML;128MG/100ML;234MG/100MLINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017385-001PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;32MG/100ML;128MG/100ML;234MG/100MLINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017385-001PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;32MG/100ML;128MG/100ML;234MG/100MLINJECTABLE / INJECTIONApproved before 1982a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54941SUPPL2018-07-23
33256SUPPL2016-03-22
571SUPPL2016-03-22
33255SUPPL2015-01-09
13125SUPPL2014-12-24
33254SUPPL2013-09-17
13124SUPPL2013-09-13