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FDA NDA · NDA211996

VYNDAQEL

tafamidis meglumine

Sponsor: FOLDRX PHARMS

APPLICATION
NDA211996
TYPE
NDA
ORIGINAL APPROVAL
2019-05-03
LATEST ACTION
2023-10-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

VYNDAQEL · ReferenceDiscontinued
TAFAMIDIS MEGLUMINE 20MG · CAPSULE · ORAL

Approval history

2023-10-17Labeling · Supplement 2 · standard — Label ↗AP
2021-06-01Labeling · Supplement 1 · standard — Letter ↗AP
2019-05-03Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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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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