FDA.reportPublic FDA data

Application 019884

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESNEXMESNAINJECTABLE;INTRAVENOUS100MG/MLYesYes

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
N019884-001MESNEXMESNA100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N019884-001AP

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 22:54:322026-06N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N019884-001AP1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MESNEXMESNABamboo US Bidco LCC1dd69e84-616d-fb77-e063-6394a90af2f42025-12-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 019884
application number: NDA019884
MESNEXMESNABaxter Healthcare Company49fdfbc3-69f8-4706-9d11-bf60e4e7811b2018-12-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 019884
application number: NDA019884
ndc (product): 0338-1305
MESNAMESNABaxter Healthcare Companyfe1683ef-0569-411e-8188-0499884632ad2018-12-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 019884
application number: NDA019884
ndc (product): 10019-953
MESNAMESNABaxter Healthcare Companya880160b-fa82-453a-a971-29ab897876a72018-12-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 019884
application number: NDA019884
ndc (product): 10019-951
MESNEXMESNABaxter Healthcare Company2e8eebc3-ea75-4c57-bfe1-2c5dc2c378062018-07-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 019884
application number: NDA019884
ndc (product): 0338-1307

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-1305MESNEXmesnaBaxter Healthcare CorporationNDACurrent
0338-1305MESNEXmesnaBaxter Healthcare CorporationNDACurrent
0338-1305MESNEXmesnaBaxter Healthcare CorporationNDACurrent
0338-1305MESNEXmesnaBaxter Healthcare CorporationNDACurrent
0338-1307MESNEXMESNABaxter Healthcare CorporationNDACurrent
0338-1307MESNEXMESNABaxter Healthcare CorporationNDACurrent
10019-951MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-951MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-951MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-951MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-953MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-953MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-953MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-953MESNAMESNABaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56920SUPPL2018-12-21
56760SUPPL2018-12-18
11806SUPPL2014-03-19
1751SUPPL2014-03-19
19789SUPPL2003-01-30
1750SUPPL2003-01-30