FDA.reportPublic FDA data

Application 074206

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOBUTAMINE HYDROCHLORIDEDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 12.5MG BASE/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
A074206-001DOBUTAMINE HYDROCHLORIDEDOBUTAMINE HYDROCHLORIDEEQ 12.5MG BASE/MLINJECTABLE / INJECTION1993-10-19

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 22:54:322026-06A074206-001DOBUTAMINE HYDROCHLORIDEEQ 12.5MG BASE/MLINJECTABLE / INJECTION1993-10-19a50c72e98297…

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
DOBUTAMINE HYDROCHLORIDEDOBUTAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc6ceb8d3-e46e-f0da-e053-2995a90a8c3c2024-01-30Warnings, Adverse reactionsName fallback
brand name: DOBUTAMINE HYDROCHLORIDE
generic name: DOBUTAMINE HYDROCHLORIDE
Dobutamine Hydrochloride in DextroseDOBUTAMINE HYDROCHLORIDEBaxter Healthcare Corporation6b17b98b-e06d-42ed-925f-69aa2699dead2023-09-08Warnings, Adverse reactionsName fallback
generic name: DOBUTAMINE HYDROCHLORIDE