FDA.reportPublic FDA data

Application 078980

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MITOXANTRONE HYDROCHLORIDEMITOXANTRONE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 20MG BASE/10ML (EQ 2MG BASE/ML)NoNo
002MITOXANTRONE HYDROCHLORIDEMITOXANTRONE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 30MG BASE/15ML (EQ 2MG BASE/ML)NoNo

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
A078980-001MITOXANTRONE HYDROCHLORIDEMITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13
A078980-002MITOXANTRONE HYDROCHLORIDEMITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078980-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A078980-002MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTION2009-04-13782e0a99824c…

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
MitoxantroneMITOXANTRONE HYDROCHLORIDEFresenius Kabi USA, LLCfcb8ef8a-f770-4416-8fc5-fa01d98c8eee2024-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOXANTRONE HYDROCHLORIDE