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)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690080ANDAPfizer Labs2012-12-12MITOXANTRONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA201014c101cb05-faaa-44cb-9666-c8214628c844
2007034680ANDATeva Parenteral Medicines, Inc2006-04-11MITOXANTRONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA0773564d0f0f1a-31af-40fa-9c64-e90891fa6ce4
3007034685ANDATeva Parenteral Medicines, Inc2006-04-11MITOXANTRONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA0773564d0f0f1a-31af-40fa-9c64-e90891fa6ce4
4007034686ANDATeva Parenteral Medicines, Inc2006-04-11MITOXANTRONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA0773564d0f0f1a-31af-40fa-9c64-e90891fa6ce4
5617030343ANDAHospira Worldwide, Inc.2006-04-11MITOXANTRONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA076871accf9569-4b57-4e83-a7db-4e890a75d1ba
6633230132ANDAApp Pharmaceuticals, Llc2006-04-11MITOXANTRONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA077496fcb8ef8a-f770-4416-8fc5-fa01d98c8eee

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076611MITOXANTRONE HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2006-04-11ANDA076611_001, ANDA076611_002, ANDA076611_003
2ANDA076871MITOXANTRONE HYDROCHLORIDEHOSPIRA WORLDWIDE, INC2006-04-11ANDA076871_001, ANDA076871_002, ANDA076871_003
3ANDA077356MITOXANTRONE HYDROCHLORIDETEVA PHARMACEUTICALS USA2006-04-11ANDA077356_001, ANDA077356_002, ANDA077356_003
4ANDA077496MITOXANTRONE HYDROCHLORIDEFRESENIUS KABI USA LLC2006-04-11ANDA077496_001, ANDA077496_002, ANDA077496_003
5ANDA078606MITOXANTRONE HYDROCHLORIDETrueFRESENIUS KABI ONCOLOGY PLC2008-05-14ANDA078606_001, ANDA078606_002, ANDA078606_003
6ANDA078980MITOXANTRONE HYDROCHLORIDEMYLAN INSTITUTIONAL LLC2009-04-13ANDA078980_001, ANDA078980_002
7ANDA201014MITOXANTRONE HYDROCHLORIDEMYLAN LABORATORIES LTD2012-12-11ANDA201014_001
8NDA019297NOVANTRONETrueEMD SERONO INC1987-12-23NDA019297_001, NDA019297_002, NDA019297_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076611_001RXMITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML)INJECTIONFalseAP2006-04-11MITOXANTRONE HYDROCHLORIDE
2ANDA076611_002RXMITOXANTRONE HYDROCHLORIDE (EQ 25MG BASE/12.5ML)INJECTIONFalseAP2006-04-11MITOXANTRONE HYDROCHLORIDE
3ANDA076611_003RXMITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML)INJECTIONFalseAP2006-04-11MITOXANTRONE HYDROCHLORIDE
4ANDA076871_001RXMITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML)INJECTIONTrueAP2006-04-11MITOXANTRONE HYDROCHLORIDE
5ANDA076871_002RXMITOXANTRONE HYDROCHLORIDE (EQ 25MG BASE/12.5ML)INJECTIONTrueAP2006-04-11MITOXANTRONE HYDROCHLORIDE
6ANDA076871_003RXMITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML)INJECTIONTrueAP2006-04-11MITOXANTRONE HYDROCHLORIDE
7ANDA077356_001RXMITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML)INJECTIONFalseAP2006-04-11MITOXANTRONE HYDROCHLORIDE
8ANDA077356_002RXMITOXANTRONE HYDROCHLORIDE (EQ 25MG BASE/12.5ML)INJECTIONFalseAP2006-04-11MITOXANTRONE HYDROCHLORIDE
9ANDA077356_003RXMITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML)INJECTIONFalseAP2006-04-11MITOXANTRONE HYDROCHLORIDE
10ANDA077496_001RXMITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML)INJECTIONFalseAP2006-04-11MITOXANTRONE HYDROCHLORIDE
11ANDA077496_002RXMITOXANTRONE HYDROCHLORIDE (EQ 25MG BASE/12.5ML)INJECTIONFalseAP2006-04-11MITOXANTRONE HYDROCHLORIDE
12ANDA077496_003RXMITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML)INJECTIONFalseAP2006-04-11MITOXANTRONE HYDROCHLORIDE
13ANDA078606_001discontinuedMITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML)INJECTIONFalse2008-05-14MITOXANTRONE HYDROCHLORIDE
14ANDA078606_002discontinuedMITOXANTRONE HYDROCHLORIDE (EQ 25MG BASE/12.5ML)INJECTIONFalse2008-05-14MITOXANTRONE HYDROCHLORIDE
15ANDA078606_003discontinuedMITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML)INJECTIONFalse2008-05-14MITOXANTRONE HYDROCHLORIDE
16ANDA078980_001RXMITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML)INJECTIONFalseAP2009-04-13MITOXANTRONE HYDROCHLORIDE
17ANDA078980_002RXMITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML)INJECTIONFalseAP2009-04-13MITOXANTRONE HYDROCHLORIDE
18ANDA201014_001RXMITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML)INJECTIONFalseAP2012-12-11MITOXANTRONE HYDROCHLORIDE
19NDA019297_001discontinuedMITOXANTRONE HYDROCHLORIDE (EQ 20MG BASE/10ML)INJECTIONFalse1987-12-23NOVANTRONE
20NDA019297_002discontinuedMITOXANTRONE HYDROCHLORIDE (EQ 25MG BASE/12.5ML)INJECTIONFalse1987-12-23NOVANTRONE
21NDA019297_003discontinuedMITOXANTRONE HYDROCHLORIDE (EQ 30MG BASE/15ML)INJECTIONFalse1987-12-23NOVANTRONE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14d0f0f1a-31af-40fa-9c64-e90891fa6ce4 (view SPL)mitoXANTRONE Injection USP (concentrate)prescriptionHuman PrescriptionTeva Parenteral Medicines, IncANALYSIS, LABEL, MANUFACTURE, PACK2012-06-154007034680, 007034685, 007034686
2accf9569-4b57-4e83-a7db-4e890a75d1ba (view SPL)MitoXANTRONE Injection, USP(concentrate)prescriptionHuman PrescriptionHospira Worldwide, Inc.2015-08-2116617030343
3c101cb05-faaa-44cb-9666-c8214628c844 (view SPL)Mitoxantrone Injection USP (Concentrate)prescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2013-05-151000690080
4fcb8ef8a-f770-4416-8fc5-fa01d98c8eee (view SPL)Mitoxantrone Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-06-114633230132

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII