Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 213947

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

Active Ingredient: TIROFIBAN HYDROCHLORIDE
Proprietary Name: TIROFIBAN HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213947
Product Number: 001
Approval Date: Feb 7, 2023
Applicant Holder Full Name: NEXUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: TIROFIBAN HYDROCHLORIDE
Proprietary Name: TIROFIBAN HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213947
Product Number: 002
Approval Date: Jul 24, 2023
Applicant Holder Full Name: NEXUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information