FDA.reportPublic FDA data

Application 065411

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEINJECTABLE;INJECTION200MG/100ML (2MG/ML)NoNo
002EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEINJECTABLE;INJECTION50MG/25ML (2MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065411-001EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-20
A065411-002EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-20

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 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-2084e616aacf4f…
2026-09-14 22:38:342026-08A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-2084e616aacf4f…
2026-08-18 06:07:402026-07A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-20caaa826d4ba7…
2026-08-18 06:07:402026-07A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065411-001EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2007-08-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065411-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2007-08-2074a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A065411-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065411-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065411-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065411-002AP1ea99ee380514…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EllenceEPIRUBICIN HYDROCHLORIDEPharmacia & Upjohn Company LLC0a03c798-a652-4895-b29c-3b521a89ba422026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: EPIRUBICIN HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-151Epirubicin Hydrochlorideepirubicin hydrochlorideFresenius Kabi USA, LLCANDACurrent