FDA.reportPublic FDA data

Application 017863

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SORBITOL 3% IN PLASTIC CONTAINERSORBITOLSOLUTION;IRRIGATION3GM/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N017863-001SORBITOL 3% IN PLASTIC CONTAINERSORBITOL3GM/100MLSOLUTION / IRRIGATIONApproved 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N017863-001SORBITOL 3% IN PLASTIC CONTAINER3GM/100MLSOLUTION / IRRIGATIONApproved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SorbitolSORBITOLBaxter Healthcare Corporationaea0b5a1-444b-4330-a3ce-26485dbbfe752019-12-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 017863
application number: NDA017863
ndc (product): 0338-0295

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0295SorbitolSorbitolBaxter Healthcare CorporationNDACurrent
0338-0295SorbitolSorbitolBaxter Healthcare CorporationNDACurrent
0338-0295SorbitolSorbitolBaxter Healthcare CorporationNDACurrent
0338-0295SorbitolSorbitolBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13937SUPPL2004-03-28
13939SUPPL2003-08-14
13938SUPPL2002-09-03
13936SUPPL2002-07-03