Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020913
Company: MEDICURE
Company: MEDICURE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AGGRASTAT | TIROFIBAN HYDROCHLORIDE | EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
| AGGRASTAT | TIROFIBAN HYDROCHLORIDE | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | No |
| AGGRASTAT | TIROFIBAN HYDROCHLORIDE | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/11/2020 | SUPPL-28 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020913Orig1s028ReplacementLbl.pdf | |
| 05/16/2019 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020912s027,020913s026lbl.pdf | |
| 09/07/2016 | SUPPL-22 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020912s024,020913s022lbl.pdf |
| 04/21/2015 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020912s021,020913s018lbl.pdf | |
| 06/06/2012 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.pdf | |
| 07/09/1999 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_prntlbl.pdf | |
| 05/14/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20913lbl.pdf |