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FDA ANDA · ANDA204233
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Sponsor: ALEMBIC
APPLICATION
ANDA204233
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-24
LATEST ACTION
2025-08-01
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 25MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
Approval history
2025-08-01Labeling · Supplement 25 · standardAP
2021-01-21Labeling · Supplement 13 · standardAP
2017-04-24UNKNOWN · OriginalAP
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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