← FDA DRUG APPROVALS

FDA NDA · NDA208383

BEVYXXA

Sponsor: PORTOLA PHARMS INC

APPLICATION
NDA208383
TYPE
NDA
ORIGINAL APPROVAL
2017-06-23
LATEST ACTION
2020-08-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

BEVYXXA · ReferenceDiscontinued
BETRIXABAN 80MG · CAPSULE · ORAL
BEVYXXA · ReferenceDiscontinued
BETRIXABAN 40MG · CAPSULE · ORAL

Approval history

2020-08-24Labeling · Supplement 7 · standard — Letter ↗AP
2019-07-18Labeling · Supplement 6 · standard — Label ↗AP
2017-07-14Labeling · Supplement 1 · standard — Letter ↗AP
2017-06-23Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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