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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206888
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIROFIBAN HYDROCHLORIDE TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION;INTRAVENOUS Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/08/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206888Orig1s000ltr.pdf

TIROFIBAN HYDROCHLORIDE

SOLUTION;INTRAVENOUS; EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AGGRASTAT TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 020913 MEDICURE
TIROFIBAN HYDROCHLORIDE TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 206888 GLAND PHARMA LTD
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