Mitoxantrone Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Hospira Worldwide, Inc. (2015-08-21)
- Oldest Current Product
- 2006-04-11
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\MITOXANTRONE
- FDAOB
- INJECTION\INJECTION\MITOXANTRONE HYDROCHLORIDE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\MITOXANTRONE HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\MITOXANTRONE HYDROCHLORIDE - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\MITOXANTRONE
INTRAVENOUS\INJECTION, SOLUTION\MITOXANTRONE
product(s) by strength(s)
mitoxantrone 2 mg/ml injectable solution
generic product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|
1 | 000690080 | ANDA | Pfizer Labs | 2012-12-12 | MITOXANTRONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA201014 | c101cb05-faaa-44cb-9666-c8214628c844 |
2 | 007034680 | ANDA | Teva Parenteral Medicines, Inc | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | ANDA077356 | 4d0f0f1a-31af-40fa-9c64-e90891fa6ce4 |
3 | 007034685 | ANDA | Teva Parenteral Medicines, Inc | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | ANDA077356 | 4d0f0f1a-31af-40fa-9c64-e90891fa6ce4 |
4 | 007034686 | ANDA | Teva Parenteral Medicines, Inc | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | ANDA077356 | 4d0f0f1a-31af-40fa-9c64-e90891fa6ce4 |
5 | 617030343 | ANDA | Hospira Worldwide, Inc. | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | ANDA076871 | accf9569-4b57-4e83-a7db-4e890a75d1ba |
6 | 633230132 | ANDA | App Pharmaceuticals, Llc | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA077496 | fcb8ef8a-f770-4416-8fc5-fa01d98c8eee |
application(s)
# | id | title | deprecated | applicant | approved | approved drug |
---|---|---|---|---|---|---|
1 | ANDA076611 | MITOXANTRONE HYDROCHLORIDE | EUROHEALTH INTERNATIONAL SARL | 2006-04-11 | ANDA076611_001, ANDA076611_002, ANDA076611_003 | |
2 | ANDA076871 | MITOXANTRONE HYDROCHLORIDE | HOSPIRA WORLDWIDE, INC | 2006-04-11 | ANDA076871_001, ANDA076871_002, ANDA076871_003 | |
3 | ANDA077356 | MITOXANTRONE HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | 2006-04-11 | ANDA077356_001, ANDA077356_002, ANDA077356_003 | |
4 | ANDA077496 | MITOXANTRONE HYDROCHLORIDE | FRESENIUS KABI USA LLC | 2006-04-11 | ANDA077496_001, ANDA077496_002, ANDA077496_003 | |
5 | ANDA078606 | MITOXANTRONE HYDROCHLORIDE | True | FRESENIUS KABI ONCOLOGY PLC | 2008-05-14 | ANDA078606_001, ANDA078606_002, ANDA078606_003 |
6 | ANDA078980 | MITOXANTRONE HYDROCHLORIDE | MYLAN INSTITUTIONAL LLC | 2009-04-13 | ANDA078980_001, ANDA078980_002 | |
7 | ANDA201014 | MITOXANTRONE HYDROCHLORIDE | MYLAN LABORATORIES LTD | 2012-12-11 | ANDA201014_001 | |
8 | NDA019297 | NOVANTRONE | True | EMD SERONO INC | 1987-12-23 | NDA019297_001, NDA019297_002, NDA019297_003 |
application drug(s)
# | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
---|---|---|---|---|---|---|---|---|
1 | ANDA076611_001 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML) | INJECTION | False | AP | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE |
2 | ANDA076611_002 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 25MG BASE/12.5ML) | INJECTION | False | AP | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE |
3 | ANDA076611_003 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML) | INJECTION | False | AP | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE |
4 | ANDA076871_001 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML) | INJECTION | True | AP | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE |
5 | ANDA076871_002 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 25MG BASE/12.5ML) | INJECTION | True | AP | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE |
6 | ANDA076871_003 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML) | INJECTION | True | AP | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE |
7 | ANDA077356_001 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML) | INJECTION | False | AP | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE |
8 | ANDA077356_002 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 25MG BASE/12.5ML) | INJECTION | False | AP | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE |
9 | ANDA077356_003 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML) | INJECTION | False | AP | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE |
10 | ANDA077496_001 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML) | INJECTION | False | AP | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE |
11 | ANDA077496_002 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 25MG BASE/12.5ML) | INJECTION | False | AP | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE |
12 | ANDA077496_003 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML) | INJECTION | False | AP | 2006-04-11 | MITOXANTRONE HYDROCHLORIDE |
13 | ANDA078606_001 | discontinued | MITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML) | INJECTION | False | 2008-05-14 | MITOXANTRONE HYDROCHLORIDE | |
14 | ANDA078606_002 | discontinued | MITOXANTRONE HYDROCHLORIDE (EQ 25MG BASE/12.5ML) | INJECTION | False | 2008-05-14 | MITOXANTRONE HYDROCHLORIDE | |
15 | ANDA078606_003 | discontinued | MITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML) | INJECTION | False | 2008-05-14 | MITOXANTRONE HYDROCHLORIDE | |
16 | ANDA078980_001 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML) | INJECTION | False | AP | 2009-04-13 | MITOXANTRONE HYDROCHLORIDE |
17 | ANDA078980_002 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML) | INJECTION | False | AP | 2009-04-13 | MITOXANTRONE HYDROCHLORIDE |
18 | ANDA201014_001 | RX | MITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML) | INJECTION | False | AP | 2012-12-11 | MITOXANTRONE HYDROCHLORIDE |
19 | NDA019297_001 | discontinued | MITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML) | INJECTION | False | 1987-12-23 | NOVANTRONE | |
20 | NDA019297_002 | discontinued | MITOXANTRONE HYDROCHLORIDE (EQ 25MG BASE/12.5ML) | INJECTION | False | 1987-12-23 | NOVANTRONE | |
21 | NDA019297_003 | discontinued | MITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML) | INJECTION | False | 1987-12-23 | NOVANTRONE |
spl(s)
# | id | title | category | type | labeler | labeler act | last update | version | product(s) |
---|---|---|---|---|---|---|---|---|---|
1 | 4d0f0f1a-31af-40fa-9c64-e90891fa6ce4 (view SPL) | mitoXANTRONE Injection USP (concentrate) | prescription | Human Prescription | Teva Parenteral Medicines, Inc | ANALYSIS, LABEL, MANUFACTURE, PACK | 2012-06-15 | 4 | 007034680, 007034685, 007034686 |
2 | accf9569-4b57-4e83-a7db-4e890a75d1ba (view SPL) | MitoXANTRONE Injection, USP(concentrate) | prescription | Human Prescription | Hospira Worldwide, Inc. | 2015-08-21 | 16 | 617030343 | |
3 | c101cb05-faaa-44cb-9666-c8214628c844 (view SPL) | Mitoxantrone Injection USP (Concentrate) | prescription | Human Prescription | Pfizer Labs | Analysis, Manufacture, Pack, Sterilize | 2013-05-15 | 1 | 000690080 |
4 | fcb8ef8a-f770-4416-8fc5-fa01d98c8eee (view SPL) | Mitoxantrone Injection, USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2015-06-11 | 4 | 633230132 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII