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FDA ANDA · ANDA202414
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Sponsor: MACLEODS PHARMS LTD
APPLICATION
ANDA202414
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-27
LATEST ACTION
2025-11-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, None (Tentative Approval)
Products
IRBESARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 300MG · TABLET · ORAL
IRBESARTAN; HYDROCHLOROTHIAZIDENone (Tentative Approval)
IRBESARTAN: HYDROCHLOROTHIAZIDE 300MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 150MG · TABLET · ORAL
Approval history
2025-11-25Labeling · Supplement 72 · standardAP
2022-04-05Labeling · Supplement 49 · standardAP
2022-04-05Labeling · Supplement 47 · standardAP
2021-06-04Labeling · Supplement 43 · standardAP
2021-06-04Labeling · Supplement 36 · standardAP
2019-02-02Labeling · Supplement 17 · standardAP
2019-02-02Labeling · Supplement 24 · standardAP
2016-09-22Labeling · Supplement 12 · standardAP
2015-02-18Labeling · Supplement 8 · standardAP
2012-12-05Labeling · Supplement 3 · standardAP
2012-09-27UNKNOWN · OriginalTA
2012-09-27UNKNOWN · 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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