APPLICATION
ANDA216379
TYPE
ANDA
ORIGINAL APPROVAL
2023-05-01
LATEST ACTION
2023-05-01
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
TIROFIBAN HYDROCHLORIDEPrescription
TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) · SOLUTION · INTRAVENOUS
TIROFIBAN HYDROCHLORIDEPrescription
TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) · SOLUTION · INTRAVENOUS
Approval history
2023-05-01UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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