← FDA DRUG APPROVALS

FDA ANDA · ANDA091648

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Sponsor: NATCO

APPLICATION
ANDA091648
TYPE
ANDA
ORIGINAL APPROVAL
2014-02-25
LATEST ACTION
2015-10-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TELMISARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, TELMISARTAN 80MG · TABLET · ORAL
TELMISARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, TELMISARTAN 80MG · TABLET · ORAL
TELMISARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, TELMISARTAN 40MG · TABLET · ORAL

Approval history

2015-10-26Labeling · Supplement 3 · standardAP
2014-02-25Original — 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 →