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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020912

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AGGRASTAT (TIROFIBAN HYDROCHLORIDE)
EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: TIROFIBAN HYDROCHLORIDE
Proprietary Name: AGGRASTAT
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020912
Product Number: 002
Approval Date: Aug 31, 2016
Applicant Holder Full Name: MEDICURE INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
AGGRASTAT (TIROFIBAN HYDROCHLORIDE)
EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: TIROFIBAN HYDROCHLORIDE
Proprietary Name: AGGRASTAT
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020912
Product Number: 001
Approval Date: May 14, 1998
Applicant Holder Full Name: MEDICURE INTERNATIONAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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