Product Details for NDA 019836
SUPPRELIN (HISTRELIN ACETATE)
EQ 0.2MG BASE/ML
Marketing Status: Discontinued
EQ 0.5MG BASE/ML
Marketing Status: Discontinued
EQ 1MG BASE/ML
Marketing Status: Discontinued
EQ 0.2MG BASE/ML
Marketing Status: Discontinued
Active Ingredient: HISTRELIN ACETATE
Proprietary Name: SUPPRELIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.2MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019836
Product Number: 001
Approval Date: Dec 24, 1991
Applicant Holder Full Name: SHIRE DEVELOPMENT INC
Marketing Status: Discontinued
Patent and Exclusivity Information
SUPPRELIN (HISTRELIN ACETATE)
Proprietary Name: SUPPRELIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.2MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019836
Product Number: 001
Approval Date: Dec 24, 1991
Applicant Holder Full Name: SHIRE DEVELOPMENT INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 0.5MG BASE/ML
Marketing Status: Discontinued
Active Ingredient: HISTRELIN ACETATE
Proprietary Name: SUPPRELIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.5MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019836
Product Number: 002
Approval Date: Dec 24, 1991
Applicant Holder Full Name: SHIRE DEVELOPMENT INC
Marketing Status: Discontinued
Patent and Exclusivity Information
SUPPRELIN (HISTRELIN ACETATE)
Proprietary Name: SUPPRELIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.5MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019836
Product Number: 002
Approval Date: Dec 24, 1991
Applicant Holder Full Name: SHIRE DEVELOPMENT INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 1MG BASE/ML
Marketing Status: Discontinued
Active Ingredient: HISTRELIN ACETATE
Proprietary Name: SUPPRELIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019836
Product Number: 003
Approval Date: Dec 24, 1991
Applicant Holder Full Name: SHIRE DEVELOPMENT INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SUPPRELIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019836
Product Number: 003
Approval Date: Dec 24, 1991
Applicant Holder Full Name: SHIRE DEVELOPMENT INC
Marketing Status: Discontinued
Patent and Exclusivity Information