Application 077496

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	No	No
002	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	No	No
003	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077496-001	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11
A077496-002	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11
A077496-003	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077496-001	AP
A077496-002	AP
A077496-003	AP

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077496-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077496-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077496-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077496-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077496-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077496-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077496-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077496-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077496-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077496-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077496-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077496-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077496-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077496-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077496-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077496-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077496-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077496-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077496-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077496-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077496-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077496-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077496-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077496-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077496-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077496-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077496-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077496-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077496-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077496-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077496-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077496-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077496-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077496-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077496-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077496-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077496-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077496-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077496-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077496-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077496-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077496-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077496-001	AP	1	`8072bd15b7f6…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mitoxantrone	MITOXANTRONE HYDROCHLORIDE	Fresenius Kabi USA, LLC	fcb8ef8a-f770-4416-8fc5-fa01d98c8eee	2024-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077496 application number: ANDA077496 ndc (product): 63323-132

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-132	Mitoxantrone	MITOXANTRONE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-132	Mitoxantrone	MITOXANTRONE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31250	ORIG	2006-04-13