← FDA DRUG APPROVALS

FDA NDA · NDA219423

WIDAPLIK

telmisartan, amlodipine and indapamide

Sponsor: AZURITY

APPLICATION
NDA219423
TYPE
NDA
ORIGINAL APPROVAL
2025-06-05
LATEST ACTION
2026-05-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

WIDAPLIK · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, INDAPAMIDE 2.5MG, TELMISARTAN 40MG · TABLET · ORAL
WIDAPLIK · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 1.25MG BASE, INDAPAMIDE 0.625MG, TELMISARTAN 10MG · TABLET · ORAL
WIDAPLIK · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 2.5MG BASE, INDAPAMIDE 1.25MG, TELMISARTAN 20MG · TABLET · ORAL

Approval history

2026-05-28Labeling · Supplement 2 · standard — Letter ↗AP
2025-06-05Type 4 - New Combination · Original · standard — Letter ↗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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