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 44.

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.

Product history page 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A065037-001IDARUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION2002-05-01f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065037-002IDARUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTION2002-05-01f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065037-003IDARUBICIN HYDROCHLORIDE5MG/VIALINJECTABLE / INJECTION2002-05-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065037-001IDARUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION2002-05-01e64feba35796…
2022-09-29 23:25 UTC2022-09A065037-002IDARUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTION2002-05-01e64feba35796…
2022-09-29 23:25 UTC2022-09A065037-003IDARUBICIN HYDROCHLORIDE5MG/VIALINJECTABLE / INJECTION2002-05-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065037-001IDARUBICIN HYDROCHLORIDE20MG/VIALINJECTABLE / INJECTION2002-05-01cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065037-002IDARUBICIN HYDROCHLORIDE10MG/VIALINJECTABLE / INJECTION2002-05-01cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065037-003IDARUBICIN HYDROCHLORIDE5MG/VIALINJECTABLE / INJECTION2002-05-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065037-001IDARUBICIN HYDROCHLORIDE20MG/VIALPOWDER / INTRAVENOUS2002-05-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065037-002IDARUBICIN HYDROCHLORIDE10MG/VIALPOWDER / INTRAVENOUS2002-05-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065037-003IDARUBICIN HYDROCHLORIDE5MG/VIALPOWDER / INTRAVENOUS2002-05-01a50c72e98297…

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 · 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

Reported adverse events (FAERS/openFDA)#

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

Documents#

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