← FDA DRUG APPROVALS

FDA NDA · NDA210491

SYMDEKO

tezacaftor and ivacaftor

Sponsor: VERTEX PHARMS INC

APPLICATION
NDA210491
TYPE
NDA
ORIGINAL APPROVAL
2018-02-12
LATEST ACTION
2026-03-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SYMDEKO (COPACKAGED) · ReferencePrescription
IVACAFTOR 150MG, IVACAFTOR, TEZACAFTOR 150MG, 100MG · TABLET · ORAL
SYMDEKO (COPACKAGED) · ReferencePrescription
IVACAFTOR 75MG, IVACAFTOR, TEZACAFTOR 75MG, 50MG · TABLET · ORAL

Approval history

2026-03-17Labeling · Supplement 14 · 901 required — Label ↗AP
2025-09-25Labeling · Supplement 13 · standard — Letter ↗AP
2023-08-03Labeling · Supplement 11 · standard — Label ↗AP
2020-12-21Efficacy · Supplement 7 · priority — Letter ↗AP
2019-12-27Labeling · Supplement 5 · standard — Letter ↗AP
2019-06-21Efficacy · Supplement 3 · priority — Letter ↗AP
2018-02-12Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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