FDA.reportPublic FDA data

Application 080575

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THIAMINE HYDROCHLORIDETHIAMINE HYDROCHLORIDEINJECTABLE;INJECTION100MG/MLNoNo

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
A080575-001THIAMINE HYDROCHLORIDETHIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAPApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A080575-001AP

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 22:54:322026-06A080575-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAPApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A080575-001AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEREMEDYREPACK INC.0f38c4ba-cebf-49f4-b0a6-8a5d3ebf618c2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080575
application number: ANDA080575
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.63f3631b-ba1e-430c-a30b-dd05b2c00c132024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080575
application number: ANDA080575
ndc (product): 0641-6228

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6228Thiamine HydrochlorideThiamine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6228Thiamine HydrochlorideThiamine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent