← FDA DRUG APPROVALS
FDA ANDA · ANDA204169
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Sponsor: MACLEODS PHARMS LTD
APPLICATION
ANDA204169
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-02
LATEST ACTION
2025-03-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TELMISARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, TELMISARTAN 40MG · TABLET · ORAL
TELMISARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, TELMISARTAN 80MG · TABLET · ORAL
TELMISARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, TELMISARTAN 80MG · TABLET · ORAL
Approval history
2025-03-21Labeling · Supplement 25 · standardAP
2023-06-07Labeling · Supplement 23 · standardAP
2021-12-10Labeling · Supplement 18 · standardAP
2019-11-06Labeling · Supplement 7 · standardAP
2016-11-21Labeling · Supplement 1 · standardAP
2015-11-02UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.