FDA.reportPublic FDA data

Application 077356

Type
ANDA
Sponsor
TEVA PHARMS USA

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 25MG BASE/12.5ML (EQ 2MG BASE/ML)NoNo
003MITOXANTRONE HYDROCHLORIDEMITOXANTRONE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 30MG BASE/15ML (EQ 2MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-4680mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4680mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4680mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4680mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4680mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4685mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4685mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4685mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4685mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4685mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4686mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4686mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4686mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4686mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent
0703-4686mitoXANTRONEmitoXANTRONETeva Parenteral Medicines, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9038ORIG2006-04-12