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FDA ANDA · ANDA208847
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Sponsor: UMEDICA
APPLICATION
ANDA208847
TYPE
ANDA
ORIGINAL APPROVAL
2019-09-17
LATEST ACTION
2025-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
Approval history
2025-10-10Labeling · Supplement 19 · standardAP
2021-01-25Labeling · Supplement 2 · standardAP
2019-09-17UNKNOWN · Original · standardAP
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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