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FDA ANDA · ANDA075926

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA075926
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-01
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2020-08-20Labeling · Supplement 16 · standardAP
2020-07-30Labeling · Supplement 15 · standardAP
2006-01-23Labeling · Supplement 13AP
2003-03-21Labeling · Supplement 3AP
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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