Product Details for NDA 019297
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EQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MITOXANTRONE HYDROCHLORIDE
Proprietary Name: NOVANTRONE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019297
Product Number: 001
Approval Date: Dec 23, 1987
Applicant Holder Full Name: EMD SERONO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
NOVANTRONE (MITOXANTRONE HYDROCHLORIDE)
Proprietary Name: NOVANTRONE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019297
Product Number: 001
Approval Date: Dec 23, 1987
Applicant Holder Full Name: EMD SERONO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MITOXANTRONE HYDROCHLORIDE
Proprietary Name: NOVANTRONE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019297
Product Number: 002
Approval Date: Dec 23, 1987
Applicant Holder Full Name: EMD SERONO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
NOVANTRONE (MITOXANTRONE HYDROCHLORIDE)
Proprietary Name: NOVANTRONE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019297
Product Number: 002
Approval Date: Dec 23, 1987
Applicant Holder Full Name: EMD SERONO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MITOXANTRONE HYDROCHLORIDE
Proprietary Name: NOVANTRONE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019297
Product Number: 003
Approval Date: Dec 23, 1987
Applicant Holder Full Name: EMD SERONO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: NOVANTRONE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019297
Product Number: 003
Approval Date: Dec 23, 1987
Applicant Holder Full Name: EMD SERONO INC
Marketing Status: Discontinued
Patent and Exclusivity Information