FDA.reportPublic FDA data

Application 065037

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDEINJECTABLE;INJECTION20MG/VIALNoNo
002IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDEINJECTABLE;INJECTION10MG/VIALNoNo
003IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDEINJECTABLE;INJECTION5MG/VIALNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065037-001IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE20MG/VIALPOWDER / INTRAVENOUS2002-05-01
A065037-002IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE10MG/VIALPOWDER / INTRAVENOUS2002-05-01
A065037-003IDARUBICIN HYDROCHLORIDEIDARUBICIN HYDROCHLORIDE5MG/VIALPOWDER / INTRAVENOUS2002-05-01

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 22:54:322026-06A065037-001IDARUBICIN HYDROCHLORIDE20MG/VIALPOWDER / INTRAVENOUS2002-05-01a50c72e98297…
2026-08-01 22:54:322026-06A065037-002IDARUBICIN HYDROCHLORIDE10MG/VIALPOWDER / INTRAVENOUS2002-05-01a50c72e98297…
2026-08-01 22:54:322026-06A065037-003IDARUBICIN HYDROCHLORIDE5MG/VIALPOWDER / INTRAVENOUS2002-05-01a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Idamycin PFSIDARUBICIN HYDROCHLORIDEPfizer Laboratories Div Pfizer Inc0a5a6d93-cc1e-4d7f-8da1-446c134503b32026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IDARUBICIN HYDROCHLORIDE
Idarubicin HydrochlorideIDARUBICIN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.d31254be-6bd2-4ac1-acab-bc00e2209d282025-05-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Idarubicin Hydrochloride
generic name: IDARUBICIN HYDROCHLORIDE
Idarubicin HydrochlorideIDARUBICIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.7c20b574-285b-49eb-a98e-6752e4bb481d2025-01-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Idarubicin Hydrochloride
generic name: IDARUBICIN HYDROCHLORIDE
Idarubicin HydrochlorideIDARUBICIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b9b337d5-50f7-4ea9-9df4-72c86e4c0b912023-04-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Idarubicin Hydrochloride
generic name: IDARUBICIN HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8378ORIG2003-04-09