Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020913

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AGGRASTAT (TIROFIBAN HYDROCHLORIDE)
EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: TIROFIBAN HYDROCHLORIDE
Proprietary Name: AGGRASTAT
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020913
Product Number: 002
Approval Date: May 17, 2002
Applicant Holder Full Name: MEDICURE INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AGGRASTAT (TIROFIBAN HYDROCHLORIDE)
EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: TIROFIBAN HYDROCHLORIDE
Proprietary Name: AGGRASTAT
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020913
Product Number: 003
Approval Date: Apr 20, 2000
Applicant Holder Full Name: MEDICURE INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AGGRASTAT (TIROFIBAN HYDROCHLORIDE)
EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)
Marketing Status: Discontinued

Active Ingredient: TIROFIBAN HYDROCHLORIDE
Proprietary Name: AGGRASTAT
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020913
Product Number: 001
Approval Date: May 14, 1998
Applicant Holder Full Name: MEDICURE INTERNATIONAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information