Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208383
Company: PORTOLA PHARMS INC
Company: PORTOLA PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BEVYXXA | BETRIXABAN | 40MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
BEVYXXA | BETRIXABAN | 80MG | CAPSULE;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
06/23/2017 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208383Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208383Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/24/2020 | SUPPL-7 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208383s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208383Orig1s007ltr.pdf | |
07/18/2019 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208383s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208383Orig1s006ltr.pdf | |
07/14/2017 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208383Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/24/2020 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208383s007lbl.pdf | |
07/18/2019 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208383s006lbl.pdf | |
07/14/2017 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s001lbl.pdf | |
06/23/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf |