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FDA ANDA · ANDA207037
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Sponsor: ALKEM LABS LTD
APPLICATION
ANDA207037
TYPE
ANDA
ORIGINAL APPROVAL
2024-07-11
LATEST ACTION
2026-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
Approval history
2026-04-23Labeling · Supplement 2 · standardAP
2024-07-11UNKNOWN · 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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