FDA.reportPublic FDA data

Application 018632

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STERILE WATER FOR INJECTION IN PLASTIC CONTAINERSTERILE WATER FOR INJECTIONLIQUID;N/A100%YesYes
002STERILE WATER FOR INJECTION IN PLASTIC CONTAINERSTERILE WATER FOR INJECTIONLIQUID;N/A100%YesYes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018632-001STERILE WATER FOR INJECTION IN PLASTIC CONTAINERSTERILE WATER FOR INJECTION100%LIQUID / N/AAPRLD, RS1982-06-30
N018632-002STERILE WATER FOR INJECTION IN PLASTIC CONTAINERSTERILE WATER FOR INJECTION100%LIQUID / N/AAPRLD, RS1988-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N018632-001AP
N018632-002AP

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 22:54:322026-06N018632-001STERILE WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-06-30a50c72e98297…
2026-08-01 22:54:322026-06N018632-002STERILE WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1988-04-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N018632-001AP1a50c72e98297…
2026-08-01 22:54:322026-06N018632-002AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 018632
application number: NDA018632
ndc (product): 0338-0013
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 018632
application number: NDA018632
ndc (product): 0338-0013

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent
0338-0013Sterile WaterWaterBaxter Healthcare CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33527SUPPL2016-06-01
15051SUPPL2016-05-31