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FDA ANDA · ANDA075869

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Sponsor: TEVA

APPLICATION
ANDA075869
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-01
LATEST ACTION
2020-07-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LISINOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 20MG · TABLET · ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, LISINOPRIL 20MG · TABLET · ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 10MG · TABLET · ORAL

Approval history

2020-07-07Labeling · Supplement 17 · standardAP
2020-07-07Labeling · Supplement 18 · standardAP
2009-03-27Labeling · Supplement 16AP
2007-01-19Labeling · Supplement 12AP
2006-05-01Labeling · Supplement 11AP
2004-10-20Labeling · Supplement 9AP
2003-07-14Labeling · Supplement 4AP
2002-07-01OriginalLetterAP
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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