Product Details for NDA 018123
FACTREL (GONADORELIN HYDROCHLORIDE)
EQ 0.1MG BASE/VIAL
Marketing Status: Discontinued
EQ 0.2MG BASE/VIAL
Marketing Status: Discontinued
EQ 0.5MG BASE/VIAL
Marketing Status: Discontinued
EQ 0.1MG BASE/VIAL
Marketing Status: Discontinued
Active Ingredient: GONADORELIN HYDROCHLORIDE
Proprietary Name: FACTREL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.1MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N018123
Product Number: 001
Approval Date: Sep 30, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
FACTREL (GONADORELIN HYDROCHLORIDE)
Proprietary Name: FACTREL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.1MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N018123
Product Number: 001
Approval Date: Sep 30, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 0.2MG BASE/VIAL
Marketing Status: Discontinued
Active Ingredient: GONADORELIN HYDROCHLORIDE
Proprietary Name: FACTREL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.2MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N018123
Product Number: 002
Approval Date: Sep 30, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
FACTREL (GONADORELIN HYDROCHLORIDE)
Proprietary Name: FACTREL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.2MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N018123
Product Number: 002
Approval Date: Sep 30, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 0.5MG BASE/VIAL
Marketing Status: Discontinued
Active Ingredient: GONADORELIN HYDROCHLORIDE
Proprietary Name: FACTREL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.5MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N018123
Product Number: 003
Approval Date: Sep 30, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: FACTREL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.5MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N018123
Product Number: 003
Approval Date: Sep 30, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information