← FDA DRUG APPROVALS

FDA ANDA · ANDA203010

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Sponsor: ALEMBIC

APPLICATION
ANDA203010
TYPE
ANDA
ORIGINAL APPROVAL
2014-02-25
LATEST ACTION
2023-09-12
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

2023-09-12Labeling · Supplement 28 · standardAP
2022-01-14Labeling · Supplement 19 · standardAP
2019-11-06Labeling · Supplement 11 · standardAP
2016-03-29Labeling · Supplement 1 · standardAP
2016-03-29Labeling · Supplement 4 · standardAP
2016-03-29Labeling · Supplement 2 · standardAP
2014-02-25UNKNOWN · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →