Product Details for NDA 020239
KYTRIL (GRANISETRON HYDROCHLORIDE)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: GRANISETRON HYDROCHLORIDE
Proprietary Name: KYTRIL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020239
Product Number: 003
Approval Date: Sep 17, 2004
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
KYTRIL (GRANISETRON HYDROCHLORIDE)
Proprietary Name: KYTRIL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020239
Product Number: 003
Approval Date: Sep 17, 2004
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: GRANISETRON HYDROCHLORIDE
Proprietary Name: KYTRIL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020239
Product Number: 004
Approval Date: Mar 11, 1994
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
KYTRIL (GRANISETRON HYDROCHLORIDE)
Proprietary Name: KYTRIL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
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: N020239
Product Number: 004
Approval Date: Mar 11, 1994
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: GRANISETRON HYDROCHLORIDE
Proprietary Name: KYTRIL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 3MG 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: N020239
Product Number: 001
Approval Date: Dec 29, 1993
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
KYTRIL (GRANISETRON HYDROCHLORIDE)
Proprietary Name: KYTRIL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 3MG 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: N020239
Product Number: 001
Approval Date: Dec 29, 1993
Applicant Holder Full Name: HOFFMANN LA ROCHE 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: GRANISETRON HYDROCHLORIDE
Proprietary Name: KYTRIL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
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: N020239
Product Number: 002
Approval Date: Mar 11, 1994
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: KYTRIL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
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: N020239
Product Number: 002
Approval Date: Mar 11, 1994
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information