FDA.reportPublic FDA data

Application 064212

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAUNORUBICIN HYDROCHLORIDEDAUNORUBICIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 20MG BASE/VIALNoNo
002DAUNORUBICIN HYDROCHLORIDEDAUNORUBICIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 50MG BASE/VIALNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A064212-001DAUNORUBICIN HYDROCHLORIDEDAUNORUBICIN HYDROCHLORIDEEQ 20MG BASE/VIALINJECTABLE / INJECTION1998-06-23
A064212-002DAUNORUBICIN HYDROCHLORIDEDAUNORUBICIN HYDROCHLORIDEEQ 50MG BASE/VIALINJECTABLE / INJECTION1999-05-03

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 22:54:322026-06A064212-001DAUNORUBICIN HYDROCHLORIDEEQ 20MG BASE/VIALINJECTABLE / INJECTION1998-06-23a50c72e98297…
2026-08-01 22:54:322026-06A064212-002DAUNORUBICIN HYDROCHLORIDEEQ 50MG BASE/VIALINJECTABLE / INJECTION1999-05-03a50c72e98297…

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
Daunorubicin HydrochlorideDAUNORUBICIN HYDROCHLORIDEHisun Pharmaceuticals USA, Inc.9705fa12-499e-41a3-8fb4-f6df0858b8512026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Daunorubicin Hydrochloride
generic name: DAUNORUBICIN HYDROCHLORIDE
daunorubicin hydrochlorideDAUNORUBICIN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.ff6b9bd4-8a9f-400f-a0b9-70e25fa8a28f2025-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: daunorubicin hydrochloride
generic name: DAUNORUBICIN HYDROCHLORIDE
Daunorubicin HydrochlorideDAUNORUBICIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.227784a8-ce68-4dd4-8ac5-a652659696772024-02-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Daunorubicin Hydrochloride
generic name: DAUNORUBICIN HYDROCHLORIDE
Daunorubicin HydrochlorideDAUNORUBICIN HYDROCHLORIDEHisun Pharmaceuticals USA, Inc.f4312095-3c21-296b-e053-2995a90a0d9c2023-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Daunorubicin Hydrochloride
generic name: DAUNORUBICIN HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8359ORIG1998-06-23