← FDA DRUG APPROVALS

FDA NDA · NDA020033

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Sponsor: VALIDUS PHARMS

APPLICATION
NDA020033
TYPE
NDA
ORIGINAL APPROVAL
1992-05-19
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

LOTENSIN HCT · ReferencePrescription
BENAZEPRIL HYDROCHLORIDE 20MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
LOTENSIN HCT · ReferenceDiscontinued
BENAZEPRIL HYDROCHLORIDE 5MG, HYDROCHLOROTHIAZIDE 6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LOTENSIN HCT · ReferencePrescription
BENAZEPRIL HYDROCHLORIDE 20MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
LOTENSIN HCT · ReferencePrescription
BENAZEPRIL HYDROCHLORIDE 10MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL

Approval history

2020-08-20Labeling · Supplement 63 · standard — Label ↗AP
2018-08-08Labeling · Supplement 62 · standard — Letter ↗AP
2017-08-03Labeling · Supplement 61 · standard — Label ↗AP
2016-06-03Manufacturing (CMC) · Supplement 54 · standardAP
2016-05-05Manufacturing (CMC) · Supplement 55 · standardAP
2016-02-12Manufacturing (CMC) · Supplement 53 · standardAP
2015-08-25Labeling · Supplement 52 · standard — Letter ↗AP
2015-07-07Manufacturing (CMC) · Supplement 51 · standardAP
2014-12-12Labeling · Supplement 50 · standard — Letter ↗AP
2014-08-14Manufacturing (CMC) · Supplement 49 · standardAP
2014-07-22Manufacturing (CMC) · Supplement 48 · standardAP
2012-09-21Labeling · Supplement 47 · unknown — Label ↗AP
2012-07-27Labeling · Supplement 46 · unknown — Label ↗AP
2012-02-16Labeling · Supplement 43 · unknown — Letter ↗AP
2012-01-19Labeling · Supplement 45 · unknown — Label ↗AP
2011-06-14Labeling · Supplement 41 · unknown — Label ↗AP
2011-03-17Labeling · Supplement 40 · unknown — Label ↗AP
2009-11-10Labeling · Supplement 38 · unknown — Letter ↗AP
2009-01-22Labeling · Supplement 37 · standard — Letter ↗AP
2008-05-29Labeling · Supplement 36 · standard — Letter ↗AP
2007-02-02Labeling · Supplement 33 · standard — Letter ↗AP
2003-10-29Labeling · Supplement 25 · standard — Letter ↗AP
2002-10-25Manufacturing (CMC) · Supplement 23 · standardAP
2002-09-20Manufacturing (CMC) · Supplement 22 · standardAP
2002-04-29Manufacturing (CMC) · Supplement 21 · standardAP
2001-12-14Labeling · Supplement 18 · standardAP
2001-11-30Manufacturing (CMC) · Supplement 20 · standardAP
2001-10-16Manufacturing (CMC) · Supplement 16 · standardAP
2001-08-13Manufacturing (CMC) · Supplement 19 · standardAP
2000-05-10Manufacturing (CMC) · Supplement 17 · standardAP
1999-04-28Manufacturing (CMC) · Supplement 14 · standardAP
1998-07-29Labeling · Supplement 13 · standardAP
1997-04-09Labeling · Supplement 12 · standardAP
1997-01-13Manufacturing (CMC) · Supplement 11 · standardAP
1996-04-02Labeling · Supplement 9 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 10 · standardAP
1995-05-05Labeling · Supplement 8 · standardAP
1993-12-20Labeling · Supplement 7 · standardAP
1993-10-21Labeling · Supplement 5 · standardAP
1993-06-30Manufacturing (CMC) · Supplement 6 · standardAP
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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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