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FDA ANDA · ANDA091351

TELMISARTAN AND HYDROCHLOROTHIAZIDE

Sponsor: LUPIN

APPLICATION
ANDA091351
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-07
LATEST ACTION
2023-04-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2023-04-26Labeling · Supplement 6 · standardAP
2023-04-26Labeling · Supplement 10 · standardAP
2019-05-07Labeling · Supplement 4 · standardAP
2019-05-07Labeling · Supplement 2 · standardAP
2015-11-13Labeling · Supplement 1 · standardAP
2014-08-07OriginalAP
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.

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