Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English