← FDA DRUG APPROVALS

FDA NDA · NDA019888

ZESTORETIC

lisinopril and hydrochlorothiazide

Sponsor: ALMATICA

APPLICATION
NDA019888
TYPE
NDA
ORIGINAL APPROVAL
1989-07-20
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ZESTORETIC · ReferencePrescription
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 10MG · TABLET · ORAL
ZESTORETIC · ReferencePrescription
HYDROCHLOROTHIAZIDE 12.5MG, LISINOPRIL 20MG · TABLET · ORAL
ZESTORETIC · ReferencePrescription
HYDROCHLOROTHIAZIDE 25MG, LISINOPRIL 20MG · TABLET · ORAL

Approval history

2020-08-20Labeling · Supplement 69 · standard — Label ↗AP
2017-07-21Labeling · Supplement 67 · standard — Label ↗AP
2015-08-25Labeling · Supplement 65 · standard — Label ↗AP
2014-12-24Labeling · Supplement 56 · standard — Label ↗AP
2013-11-05Labeling · Supplement 55 · standard — Label ↗AP
2012-10-31Labeling · Supplement 53 · unknown — Label ↗AP
2012-08-13Labeling · Supplement 54 · unknown — Letter ↗AP
2012-05-02Labeling · Supplement 51 · unknown — Letter ↗AP
2012-03-29Labeling · Supplement 52 · unknown — Letter ↗AP
2011-08-04Labeling · Supplement 50 · unknown — Letter ↗AP
2011-03-11Labeling · Supplement 49 · unknown — Letter ↗AP
2009-11-06Labeling · Supplement 47 · standard — Label ↗AP
2009-05-20Labeling · Supplement 45 · standard — Letter ↗AP
2007-10-04Labeling · Supplement 44 · standard — Letter ↗AP
2007-07-16Labeling · Supplement 43 · standard — Letter ↗AP
2006-06-16Labeling · Supplement 41 · standard — Letter ↗AP
2005-05-24Labeling · Supplement 40 · standard — Letter ↗AP
2003-04-17Labeling · Supplement 35 · standard — Letter ↗AP
2002-10-17Labeling · Supplement 36 · standardAP
2001-12-18Labeling · Supplement 34 · standardAP
2000-12-19Manufacturing (CMC) · Supplement 33 · standardAP
2000-12-15Manufacturing (CMC) · Supplement 32 · standardAP
2000-07-27Manufacturing (CMC) · Supplement 31 · standardAP
1999-11-18Manufacturing (CMC) · Supplement 30 · standardAP
1998-05-08Labeling · Supplement 29 · standardAP
1997-01-14Manufacturing (CMC) · Supplement 28 · standardAP
1996-10-11Manufacturing (CMC) · Supplement 27 · standardAP
1996-01-05Labeling · Supplement 26 · standardAP
1996-01-05Labeling · Supplement 24 · standardAP
1995-12-14Manufacturing (CMC) · Supplement 25 · standardAP
1995-10-26Manufacturing (CMC) · Supplement 22 · standardAP
1995-07-11Manufacturing (CMC) · Supplement 23 · standardAP
1995-06-13Labeling · Supplement 20 · standard — Review ↗AP
1995-06-13Labeling · Supplement 15 · standardAP
1995-03-31Labeling · Supplement 21 · standardAP
1994-09-15Labeling · Supplement 19 · standardAP
1994-08-05Labeling · Supplement 18 · standardAP
1994-08-05Labeling · Supplement 17 · standardAP
1994-08-05Labeling · Supplement 13 · standardAP
1993-12-09Labeling · Supplement 16 · standardAP
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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