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FDA ANDA · ANDA078276

OLMESARTAN MEDOXOMIL

Sponsor: RISING

APPLICATION
ANDA078276
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-26
LATEST ACTION
2025-09-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OLMESARTAN MEDOXOMILDiscontinued
OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
OLMESARTAN MEDOXOMILDiscontinued
OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
OLMESARTAN MEDOXOMILDiscontinued
OLMESARTAN MEDOXOMIL 5MG · TABLET · ORAL

Approval history

2025-09-12Labeling · Supplement 3 · standardAP
2025-09-12Labeling · Supplement 1 · standardAP
2016-10-26Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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