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FDA ANDA · ANDA206515

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Sponsor: TORRENT

APPLICATION
ANDA206515
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-03
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL

Approval history

2023-01-17Labeling · Supplement 13 · standardAP
2017-05-03UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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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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