Mitoxantrone (Page 11 of 11)

VIAL LABEL 20 mg/10 mL

Vial Label for Mitoxantrone 20mg/10mL
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Vial Label 20mg/10mL

VIAL LABEL 25 mg/12.5 mL

Vial Label for Mitoxantrone 25mg/12.5mL
(click image for full-size original)

Vial Label 25mg/12.5mL

VIAL LABEL 30 mg/15 mL

Vial Label for Mitoxantrone 30mg/15mL
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Vial Label 30mg/15mL

MITOXANTRONE mitoxantrone hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55390-085
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MITOXANTRONE (MITOXANTRONE) MITOXANTRONE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID 0.46 mg in 1 mL
SODIUM ACETATE 0.05 mg in 1 mL
SODIUM CHLORIDE 8 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55390-085-01 1 VIAL, MULTI-DOSE in 1 BOX contains a VIAL, MULTI-DOSE
1 15 mL in 1 VIAL, MULTI-DOSE This package is contained within the BOX (55390-085-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076611 04/11/2006
MITOXANTRONE mitoxantrone hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55390-084
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MITOXANTRONE (MITOXANTRONE) MITOXANTRONE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID 0.46 mg in 1 mL
SODIUM ACETATE 0.05 mg in 1 mL
SODIUM CHLORIDE 8 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55390-084-01 1 VIAL, MULTI-DOSE in 1 BOX contains a VIAL, MULTI-DOSE
1 12.5 mL in 1 VIAL, MULTI-DOSE This package is contained within the BOX (55390-084-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076611 04/11/2006
MITOXANTRONE mitoxantrone hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55390-083
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MITOXANTRONE (MITOXANTRONE) MITOXANTRONE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID 0.46 mg in 1 mL
SODIUM ACETATE 0.05 mg in 1 mL
SODIUM CHLORIDE 8 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55390-083-01 1 VIAL, MULTI-DOSE in 1 BOX contains a VIAL, MULTI-DOSE
1 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the BOX (55390-083-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076611 04/11/2006
Labeler — Bedford Laboratories (884528407)
Establishment
Name Address ID/FEI Operations
Ben Venue Laboratories Inc. 004327953 MANUFACTURE (55390-085), MANUFACTURE (55390-084), MANUFACTURE (55390-083)

Revised: 12/2012 Bedford Laboratories

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