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FDA NDA · NDA206316

SAVAYSA

edoxaban tosylate

Sponsor: DAIICHI SANKYO INC

APPLICATION
NDA206316
TYPE
NDA
ORIGINAL APPROVAL
2015-01-08
LATEST ACTION
2023-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SAVAYSA · ReferencePrescription
EDOXABAN TOSYLATE EQ 60MG BASE · TABLET · ORAL
SAVAYSA · ReferencePrescription
EDOXABAN TOSYLATE EQ 15MG BASE · TABLET · ORAL
SAVAYSA · ReferencePrescription
EDOXABAN TOSYLATE EQ 30MG BASE · TABLET · ORAL

Approval history

2023-10-18Efficacy · Supplement 19 · standard — Letter ↗AP
2023-10-18Efficacy · Supplement 21 · standardAP
2023-09-11Labeling · Supplement 20 · standard — Letter ↗AP
2021-11-01Labeling · Supplement 18 · standard — Letter ↗AP
2021-04-20Labeling · Supplement 17 · standard — Letter ↗AP
2020-04-21Labeling · Supplement 16 · standard — Letter ↗AP
2019-08-09Efficacy · Supplement 15 · standard — Label ↗AP
2017-09-29Labeling · Supplement 12 · standard — Letter ↗AP
2016-09-15Labeling · Supplement 4 · standard — Letter ↗AP
2016-04-25Manufacturing (CMC) · Supplement 7 · standardAP
2015-11-06Manufacturing (CMC) · Supplement 5 · standardAP
2015-10-30Manufacturing (CMC) · Supplement 3 · standardAP
2015-10-16Manufacturing (CMC) · Supplement 6 · standardAP
2015-09-10Labeling · Supplement 2 · standard — Letter ↗AP
2015-08-24Manufacturing (CMC) · Supplement 1 · standardAP
2015-01-08Type 1 - New Molecular Entity · Original · standard — Label ↗AP
2015-01-08Efficacy · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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