Application 019297

Type: NDA
Sponsor: EMD SERONO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOVANTRONE	MITOXANTRONE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	Yes	No
002	NOVANTRONE	MITOXANTRONE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	NOVANTRONE	MITOXANTRONE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N019297-001	NOVANTRONE	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23
N019297-002	NOVANTRONE	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23
N019297-003	NOVANTRONE	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23

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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2020-11-12 02:37 UTC	2020-11	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	RLD	1987-12-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION		1987-12-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION		1987-12-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019297-001	NOVANTRONE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019297-002	NOVANTRONE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019297-003	NOVANTRONE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1987-12-23	`3a93d1ddd44b…`

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	Name fallback generic name: MITOXANTRONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43618	SUPPL	2012-03-27
11472	SUPPL	2012-03-27
17353	SUPPL	2012-03-26
33719	SUPPL	2010-06-24
11471	SUPPL	2010-06-24
17352	SUPPL	2010-06-16
1278	SUPPL	2010-06-16
17351	SUPPL	2009-02-13
1277	SUPPL	2009-02-13
33718	SUPPL	2009-02-12
11470	SUPPL	2009-02-12
23548	ORIG	2008-07-29
40884	ORIG	2008-04-04
1276	SUPPL	2007-04-20
11469	SUPPL	2005-04-28
1275	SUPPL	2005-04-28
17350	SUPPL	2003-01-13
1274	SUPPL	2003-01-13
1273	SUPPL	2003-01-13
1272	SUPPL	2002-02-20
40886	SUPPL	2000-02-04
40885	SUPPL	1997-11-20