← FDA DRUG APPROVALS

FDA NDA · NDA200796

AZILSARTAN MEDOXOMIL

azilsartan kamedoxomil

Sponsor: AZURITY

APPLICATION
NDA200796
TYPE
NDA
ORIGINAL APPROVAL
2011-02-25
LATEST ACTION
2024-01-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EDARBI · ReferencePrescription
AZILSARTAN KAMEDOXOMIL EQ 80MG MEDOXOMIL · TABLET · ORAL
EDARBI · ReferencePrescription
AZILSARTAN KAMEDOXOMIL EQ 40MG MEDOXOMIL · TABLET · ORAL

Approval history

2024-01-16Labeling · Supplement 13 · standard — Label ↗AP
2020-03-06Labeling · Supplement 12 · standard — Label ↗AP
2016-10-24Labeling · Supplement 9 · standard — Letter ↗AP
2016-03-24Manufacturing (CMC) · Supplement 7 · standardAP
2014-07-23Labeling · Supplement 6 · standard — Label ↗AP
2014-04-18Labeling · Supplement 5 · standard — Letter ↗AP
2013-07-29Manufacturing (CMC) · Supplement 4 · standardAP
2012-10-04Labeling · Supplement 3 · unknown — Letter ↗AP
2011-12-14Labeling · Supplement 2 · unknown — Label ↗AP
2011-04-12Labeling · Supplement 1 · unknown — Label ↗AP
2011-02-25Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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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