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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208383
Company: PORTOLA PHARMS INC

Medication Guide

Products on NDA 208383

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208383

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

Labels for NDA 208383

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

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