← FDA DRUG APPROVALS

FDA NDA · NDA202331

EDARBYCLOR

azilsartan kamedoxomil and chlorthalidone

Sponsor: AZURITY

APPLICATION
NDA202331
TYPE
NDA
ORIGINAL APPROVAL
2011-12-20
LATEST ACTION
2020-03-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EDARBYCLOR · ReferencePrescription
AZILSARTAN KAMEDOXOMIL EQ 40MG MEDOXOMIL, CHLORTHALIDONE 12.5MG · TABLET · ORAL
EDARBYCLOR · ReferencePrescription
AZILSARTAN KAMEDOXOMIL EQ 40MG MEDOXOMIL, CHLORTHALIDONE 25MG · TABLET · ORAL

Approval history

2020-03-09Labeling · Supplement 16 · standard — Letter ↗AP
2016-10-24Labeling · Supplement 11 · standard — Letter ↗AP
2015-11-18Manufacturing (CMC) · Supplement 8 · standardAP
2015-04-16Labeling · Supplement 7 · standard — Label ↗AP
2014-07-23Labeling · Supplement 6 · standard — Label ↗AP
2014-04-18Labeling · Supplement 5 · standard — Letter ↗AP
2012-10-04Labeling · Supplement 2 · unknown — Letter ↗AP
2012-04-10Labeling · Supplement 1 · unknownAP
2011-12-20Type 4 - New Combination · Original · standard — Summary Review ↗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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