← FDA DRUG APPROVALS

FDA NDA · NDA018998

ENALAPRIL MALEATE

Sponsor: BAUSCH

APPLICATION
NDA018998
TYPE
NDA
ORIGINAL APPROVAL
1985-12-24
LATEST ACTION
2018-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VASOTEC · ReferencePrescription
ENALAPRIL MALEATE 2.5MG · TABLET · ORAL
VASOTEC · ReferencePrescription
ENALAPRIL MALEATE 20MG · TABLET · ORAL
VASOTEC · ReferencePrescription
ENALAPRIL MALEATE 5MG · TABLET · ORAL
VASOTEC · ReferencePrescription
ENALAPRIL MALEATE 10MG · TABLET · ORAL

Approval history

2018-08-01Labeling · Supplement 83 · standard — Label ↗AP
2017-07-21Labeling · Supplement 82 · standard — Label ↗AP
2015-08-25Labeling · Supplement 80 · standard — Letter ↗AP
2014-12-24Labeling · Supplement 79 · standard — Letter ↗AP
2012-09-13Labeling · Supplement 77 · unknown — Label ↗AP
2012-02-17Labeling · Supplement 76 · unknown — Letter ↗AP
2008-09-25Labeling · Supplement 71 · standard — Label ↗AP
2007-10-31Labeling · Supplement 70 · standard — Letter ↗AP
2002-10-10Manufacturing (CMC) · Supplement 64 · priority — Review ↗AP
2002-08-30Manufacturing (CMC) · Supplement 63 · priority — Letter ↗AP
2002-04-03Manufacturing (CMC) · Supplement 62 · priority — Review ↗AP
2002-02-04Manufacturing (CMC) · Supplement 61 · priority — Review ↗AP
2001-11-27Labeling · Supplement 58 · standard — Letter ↗AP
2001-02-13Efficacy · Supplement 59 · standard — Review ↗AP
1999-02-17Labeling · Supplement 57 · standard — Review ↗AP
1997-12-10Manufacturing (CMC) · Supplement 56 · priorityAP
1997-07-23Manufacturing (CMC) · Supplement 54 · priorityAP
1997-07-21Manufacturing (CMC) · Supplement 55 · priorityAP
1997-06-11Labeling · Supplement 53 · standard — Review ↗AP
1997-02-03Manufacturing (CMC) · Supplement 52 · priority — Review ↗AP
1997-01-09Manufacturing (CMC) · Supplement 51 · priority — Review ↗AP
1996-07-31Labeling · Supplement 34 · standard — Review ↗AP
1996-03-22Manufacturing (CMC) · Supplement 50 · priority — Review ↗AP
1995-09-28Labeling · Supplement 46 · standard — Review ↗AP
1995-09-19Manufacturing (CMC) · Supplement 48 · priorityAP
1995-09-19Manufacturing (CMC) · Supplement 49 · priorityAP
1995-09-19Manufacturing (CMC) · Supplement 47 · priorityAP
1994-12-12Manufacturing (CMC) · Supplement 41 · priority — Review ↗AP
1994-07-25Labeling · Supplement 45 · standard — Review ↗AP
1994-07-15Manufacturing (CMC) · Supplement 42 · priority — Review ↗AP
1994-05-16Labeling · Supplement 44 · standard — Review ↗AP
1994-05-11Labeling · Supplement 38 · standard — Review ↗AP
1994-02-18Labeling · Supplement 43 · standard — Review ↗AP
1994-01-14Labeling · Supplement 39 · standard — Review ↗AP
1993-11-04Efficacy · Supplement 32AP
1993-10-21Labeling · Supplement 40 · standard — Review ↗AP
1993-07-26Manufacturing (CMC) · Supplement 35 · priorityAP
1993-07-01Labeling · Supplement 37 · standardAP
1993-02-24Labeling · Supplement 36 · standardAP
1992-09-30Labeling · Supplement 33AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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