FDA.reportPublic FDA data

Application 065445

Type
ANDA
Sponsor
ACTAVIS TOTOWA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEINJECTABLE;INJECTION10MG/5ML (2MG/ML)NoNo
002EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEINJECTABLE;INJECTION50MG/25ML (2MG/ML)NoNo
003EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDEINJECTABLE;INJECTION200MG/100ML (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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065445-001EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-18
A065445-002EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-18
A065445-003EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-18

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-1884e616aacf4f…
2026-09-14 22:38:342026-08A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-1884e616aacf4f…
2026-09-14 22:38:342026-08A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-1884e616aacf4f…
2026-08-18 06:07:402026-07A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-18caaa826d4ba7…
2026-08-18 06:07:402026-07A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-18caaa826d4ba7…
2026-08-18 06:07:402026-07A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065445-002EPIRUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE / INJECTION2008-09-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065445-003EPIRUBICIN HYDROCHLORIDE200MG/100ML (2MG/ML)INJECTABLE / INJECTION2008-09-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065445-001EPIRUBICIN HYDROCHLORIDE10MG/5ML (2MG/ML)INJECTABLE / INJECTION2008-09-18301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065445-002AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065445-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065445-002AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065445-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065445-002AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065445-003AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065445-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065445-003AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065445-002AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065445-003AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065445-002AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065445-003AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065445-002AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065445-003AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A065445-002AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A065445-003AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065445-002AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A065445-003AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065445-002AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065445-003AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065445-002AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A065445-003AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A065445-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065445-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065445-003AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065445-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065445-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065445-003AP1ea99ee380514…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065445-002AP13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065445-003AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065445-002AP1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065445-003AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065445-002AP1e64feba35796…
2022-09-29 23:25 UTC2022-09A065445-003AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065445-002AP1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065445-003AP1cb3db0bc1861…

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1675Epirubicin HydrochlorideEpirubicin HydrochlorideImpax GenericsANDACurrent
45963-608Epirubicin HydrochlorideEpirubicin HydrochlorideActavis Pharma, Inc.ANDACurrent
45963-608Epirubicin HydrochlorideEpirubicin HydrochlorideActavis Pharma, Inc.ANDACurrent
45963-608Epirubicin HydrochlorideEpirubicin HydrochlorideActavis Pharma, Inc.ANDACurrent