Product Details for NDA 020007
ZOFRAN (ONDANSETRON HYDROCHLORIDE)
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ONDANSETRON HYDROCHLORIDE
Proprietary Name: ZOFRAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020007
Product Number: 001
Approval Date: Jan 4, 1991
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ZOFRAN PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE)
Proprietary Name: ZOFRAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020007
Product Number: 001
Approval Date: Jan 4, 1991
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ONDANSETRON HYDROCHLORIDE
Proprietary Name: ZOFRAN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020007
Product Number: 003
Approval Date: Dec 10, 1993
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ZOFRAN PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020007
Product Number: 003
Approval Date: Dec 10, 1993
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Discontinued
Patent and Exclusivity Information