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FDA ANDA · ANDA207088
OLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDE
Sponsor: MACLEODS PHARMS LTD
APPLICATION
ANDA207088
TYPE
ANDA
ORIGINAL APPROVAL
2025-07-18
LATEST ACTION
2025-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 25MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 25MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
Approval history
2025-07-18UNKNOWN · 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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