FDA.reportPublic FDA data

Application 080718

Type
ANDA
Sponsor
BEL MAR

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 43.

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
A080718-001THIAMINE HYDROCHLORIDETHIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / 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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A080718-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080718-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080718-001THIAMINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONApproved before 1982a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEREMEDYREPACK INC.0f38c4ba-cebf-49f4-b0a6-8a5d3ebf618c2026-08-31Warnings, Adverse reactionsName fallback
brand name: Thiamine Hydrochloride
generic name: THIAMINE HYDROCHLORIDE
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.764d608a-d821-4447-85e1-6af297abb4c12026-07-31Warnings, Adverse reactionsName fallback
brand name: Thiamine Hydrochloride
generic name: THIAMINE HYDROCHLORIDE
thiamine hydrochlorideTHIAMINE HYDROCHLORIDESagent Pharmaceuticals5982cf83-01d6-4acb-8373-339079b8a76e2026-07-22Warnings, Adverse reactionsName fallback
brand name: thiamine hydrochloride
generic name: THIAMINE HYDROCHLORIDE
ThiamineTHIAMINE HYDROCHLORIDEFresenius Kabi USA, LLCc3c9db74-95d4-487c-90c3-c810786fbaec2026-01-14Warnings, Adverse reactionsName fallback
generic name: THIAMINE HYDROCHLORIDE
ThiamineTHIAMINE HYDROCHLORIDEFresenius Kabi USA, LLCca4899c6-cea1-48d6-b0ae-9efcf67f6fcb2026-01-13Warnings, Adverse reactionsName fallback
generic name: THIAMINE HYDROCHLORIDE
ThiamineTHIAMINE HYDROCHLORIDEFresenius Kabi USA, LLCaf3f9344-f743-4bad-b319-53b96e13fee22026-01-09Warnings, Adverse reactionsName fallback
generic name: THIAMINE HYDROCHLORIDE
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEONESOURCE SPECIALTY PHARMA LIMITED2e957a35-83b3-47f5-ad09-216b22cc30be2025-11-20Warnings, Adverse reactionsName fallback
brand name: Thiamine Hydrochloride
generic name: THIAMINE HYDROCHLORIDE
THIAMINE HYDROCHLORIDETHIAMINE HYDROCHLORIDEHenry Schein, Inc.3bdf3b03-90cf-4416-9344-7733b193adf52025-11-07Warnings, Adverse reactionsName fallback
brand name: THIAMINE HYDROCHLORIDE
generic name: THIAMINE HYDROCHLORIDE
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEEugia US LLC4985bf3c-abe5-4bbb-9dcc-6de387d36d6b2025-10-23Warnings, Adverse reactionsName fallback
brand name: Thiamine Hydrochloride
generic name: THIAMINE HYDROCHLORIDE
THIAMINE HYDROCHLORIDETHIAMINE HYDROCHLORIDEHenry Schein, Inc.c006eca3-137a-493f-bbc4-f04e463d66f92025-09-26Warnings, Adverse reactionsName fallback
brand name: THIAMINE HYDROCHLORIDE
generic name: THIAMINE HYDROCHLORIDE
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEFosun Pharma USA Inc.3649f7b5-dcce-b246-e063-6394a90a31452025-06-19Warnings, Adverse reactionsName fallback
brand name: Thiamine Hydrochloride
generic name: THIAMINE HYDROCHLORIDE
thiamine hydrochlorideTHIAMINE HYDROCHLORIDEGland Pharma Limitedfc0265cd-d13a-477c-8c2c-8d44fd86444e2025-02-27Warnings, Adverse reactionsName fallback
brand name: thiamine hydrochloride
generic name: THIAMINE HYDROCHLORIDE
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDECamber Pharmaceuticals, Inc.2d402a31-3240-42a0-bd34-8fccd6a792d32025-02-03Warnings, Adverse reactionsName fallback
brand name: Thiamine Hydrochloride
generic name: THIAMINE HYDROCHLORIDE
ThiamineTHIAMINE HYDROCHLORIDECaplin Steriles Limited8909424c-9d5b-4e35-b2d3-da9d3316a4cc2024-05-20Warnings, Adverse reactionsName fallback
generic name: THIAMINE HYDROCHLORIDE
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.63f3631b-ba1e-430c-a30b-dd05b2c00c132024-04-11Warnings, Adverse reactionsName fallback
brand name: Thiamine Hydrochloride
generic name: THIAMINE HYDROCHLORIDE
ThiamineTHIAMINE HYDROCHLORIDEArmas Pharmaceuticals Inc.9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd92023-05-22Warnings, Adverse reactionsName fallback
generic name: THIAMINE HYDROCHLORIDE
ThiamineTHIAMINE HYDROCHLORIDENorthStar Rx LLCf4790075-a740-4550-9d4c-69a00dac354c2023-04-20Warnings, Adverse reactionsName fallback
generic name: THIAMINE HYDROCHLORIDE
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.43926cec-e483-8cf1-4d8d-5145e554d45d2022-12-30Warnings, Adverse reactionsName fallback
brand name: Thiamine Hydrochloride
generic name: THIAMINE HYDROCHLORIDE
Thiamine HydrochlorideTHIAMINE HYDROCHLORIDEMylan Institutional LLC12986d0e-b8bf-4338-9d85-07f973b354392021-04-15Warnings, Adverse reactionsName fallback
brand name: Thiamine Hydrochloride
generic name: THIAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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