← FDA DRUG APPROVALS

FDA NDA · NDA019221

VASERETIC

enalapril maleate and hydrochlorothiazide

Sponsor: BAUSCH

APPLICATION
NDA019221
TYPE
NDA
ORIGINAL APPROVAL
1986-10-31
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VASERETIC · ReferencePrescription
ENALAPRIL MALEATE 5MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
VASERETIC · ReferencePrescription
ENALAPRIL MALEATE 10MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL

Approval history

2020-08-20Labeling · Supplement 50 · standard — Label ↗AP
2017-07-21Labeling · Supplement 47 · standard — Label ↗AP
2015-08-25Labeling · Supplement 45 · standard — Label ↗AP
2014-12-24Labeling · Supplement 44 · standard — Label ↗AP
2012-09-13Labeling · Supplement 43 · unknown — Letter ↗AP
2012-02-17Labeling · Supplement 42 · unknown — Letter ↗AP
2011-03-11Labeling · Supplement 41 · unknown — Letter ↗AP
2008-09-25Labeling · Supplement 38 · standard — Letter ↗AP
2007-10-31Labeling · Supplement 37 · standard — Letter ↗AP
2002-11-01Labeling · Supplement 27 · standard — Letter ↗AP
2002-10-15Manufacturing (CMC) · Supplement 29 · standardAP
2002-02-04Manufacturing (CMC) · Supplement 28 · standardAP
2001-11-27Labeling · Supplement 26 · standard — Review ↗AP
1999-02-17Labeling · Supplement 25 · standard — Review ↗AP
1998-10-13Labeling · Supplement 24 · standard — Review ↗AP
1997-06-11Labeling · Supplement 23 · standard — Review ↗AP
1996-07-31Labeling · Supplement 13 · standardAP
1995-09-28Labeling · Supplement 21 · standardAP
1995-07-12Manufacturing (CMC) · Supplement 22 · standardAP
1995-07-12Efficacy · Supplement 15 · unknownAP
1994-07-25Labeling · Supplement 20 · standardAP
1994-05-11Labeling · Supplement 17 · standardAP
1994-02-18Labeling · Supplement 19 · standardAP
1994-01-14Labeling · Supplement 16 · standardAP
1993-10-21Labeling · Supplement 18 · standardAP
1993-02-24Labeling · Supplement 14 · standardAP
1992-09-30Labeling · Supplement 12AP
1992-09-30Manufacturing (CMC) · Supplement 9 · standardAP
1992-05-13Labeling · Supplement 11AP
1992-05-07Labeling · Supplement 10AP
1991-02-06Labeling · Supplement 7AP
1990-03-09Labeling · Supplement 6AP
1989-12-22Manufacturing (CMC) · Supplement 4 · standardAP
1989-11-30Labeling · Supplement 5AP
1989-04-18Labeling · Supplement 3AP
1989-01-10Labeling · Supplement 2AP
1987-01-30Labeling · Supplement 1AP
1986-10-31Type 4 - New Combination · Original · 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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