APPLICATION
ANDA209028
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-06
LATEST ACTION
2026-02-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TELMISARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, TELMISARTAN 80MG · TABLET · ORAL
TELMISARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, TELMISARTAN 80MG · TABLET · ORAL
TELMISARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, TELMISARTAN 40MG · TABLET · ORAL
Approval history
2026-02-17Labeling · Supplement 5 · standardAP
2026-02-17Labeling · Supplement 8 · standardAP
2026-02-17Labeling · Supplement 4 · standardAP
2026-02-17Labeling · Supplement 2 · standardAP
2017-11-06UNKNOWN · 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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