← FDA DRUG APPROVALS

FDA NDA · NDA019777

ZESTRIL

lisinopril

Sponsor: TWI PHARMS

APPLICATION
NDA019777
TYPE
NDA
ORIGINAL APPROVAL
1988-05-19
LATEST ACTION
2017-07-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ZESTRIL · ReferencePrescription
LISINOPRIL 20MG · TABLET · ORAL
ZESTRIL · ReferencePrescription
LISINOPRIL 5MG · TABLET · ORAL
ZESTRIL · ReferencePrescription
LISINOPRIL 30MG · TABLET · ORAL
ZESTRIL · ReferencePrescription
LISINOPRIL 40MG · TABLET · ORAL
ZESTRIL · ReferencePrescription
LISINOPRIL 10MG · TABLET · ORAL
ZESTRIL · ReferencePrescription
LISINOPRIL 2.5MG · TABLET · ORAL

Approval history

2017-07-21Labeling · Supplement 76 · standard — Label ↗AP
2016-04-21Labeling · Supplement 74 · standard — Letter ↗AP
2015-08-25Labeling · Supplement 73 · standard — Label ↗AP
2014-12-24Labeling · Supplement 64 · standard — Label ↗AP
2014-06-26Labeling · Supplement 57 · standard — Letter ↗AP
2013-11-05Labeling · Supplement 63 · standard — Label ↗AP
2012-10-31Labeling · Supplement 61 · unknown — Label ↗AP
2012-08-13Labeling · Supplement 62 · standard — Letter ↗AP
2012-05-02Labeling · Supplement 59 · unknown — Label ↗AP
2012-03-29Labeling · Supplement 60 · unknown — Label ↗AP
2011-08-04Labeling · Supplement 58 · unknown — Letter ↗AP
2009-11-06Labeling · Supplement 56 · standard — Label ↗AP
2009-05-20Labeling · Supplement 54 · standard — Label ↗AP
2007-10-04Labeling · Supplement 53 · standard — Letter ↗AP
2007-07-16Labeling · Supplement 52 · standard — Letter ↗AP
2006-06-16Labeling · Supplement 50 · standard — Letter ↗AP
2005-05-24Labeling · Supplement 49 · standard — Letter ↗AP
2004-03-30Labeling · Supplement 43 · standard — Letter ↗AP
2003-07-01Efficacy · Supplement 44 · standard — Letter ↗AP
2003-07-01Labeling · Supplement 42 · standard — Letter ↗AP
2002-10-17Labeling · Supplement 45 · standardAP
2000-12-19Manufacturing (CMC) · Supplement 40 · standardAP
2000-12-15Manufacturing (CMC) · Supplement 41 · standardAP
2000-07-27Manufacturing (CMC) · Supplement 39 · standardAP
2000-02-07Efficacy · Supplement 37 · standard — Letter ↗AP
1999-11-18Manufacturing (CMC) · Supplement 38 · standardAP
1999-02-24Manufacturing (CMC) · Supplement 36 · standardAP
1999-01-20Manufacturing (CMC) · Supplement 35 · standard — Review ↗AP
1998-11-06Manufacturing (CMC) · Supplement 34 · standard — Review ↗AP
1998-05-01Labeling · Supplement 33 · standard — Review ↗AP
1997-01-08Labeling · Supplement 32 · standard — Review ↗AP
1996-10-11Manufacturing (CMC) · Supplement 31 · standard — Review ↗AP
1995-11-24Efficacy · Supplement 23 · standardAP
1995-11-15Labeling · Supplement 30 · standard — Review ↗AP
1995-10-26Manufacturing (CMC) · Supplement 28 · standardAP
1995-07-11Manufacturing (CMC) · Supplement 26 · standard — Review ↗AP
1995-07-11Manufacturing (CMC) · Supplement 27 · standard — Review ↗AP
1995-06-13Labeling · Supplement 20 · standardAP
1995-06-05Manufacturing (CMC) · Supplement 24 · standard — Review ↗AP
1995-03-31Labeling · Supplement 25 · standardAP
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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