Product Details for NDA 200199
TOPOTECAN (TOPOTECAN HYDROCHLORIDE)
EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TOPOTECAN HYDROCHLORIDE
Proprietary Name: TOPOTECAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N200199
Product Number: 001
Approval Date: Feb 25, 2011
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TOPOTECAN (TOPOTECAN HYDROCHLORIDE)
Proprietary Name: TOPOTECAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N200199
Product Number: 001
Approval Date: Feb 25, 2011
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TOPOTECAN HYDROCHLORIDE
Proprietary Name: TOPOTECAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N200199
Product Number: 002
Approval Date: Feb 25, 2011
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TOPOTECAN (TOPOTECAN HYDROCHLORIDE)
Proprietary Name: TOPOTECAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 3MG BASE/3ML (EQ 1MG 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: N200199
Product Number: 002
Approval Date: Feb 25, 2011
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TOPOTECAN HYDROCHLORIDE
Proprietary Name: TOPOTECAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 4MG BASE/4ML (EQ 1MG 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: N200199
Product Number: 003
Approval Date: Feb 25, 2011
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: TOPOTECAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 4MG BASE/4ML (EQ 1MG 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: N200199
Product Number: 003
Approval Date: Feb 25, 2011
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Discontinued
Patent and Exclusivity Information