APPLICATION
ANDA075743
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-01
LATEST ACTION
2020-04-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LISINOPRILPrescription
LISINOPRIL 40MG · TABLET · ORAL
LISINOPRILPrescription
LISINOPRIL 20MG · TABLET · ORAL
LISINOPRILPrescription
LISINOPRIL 5MG · TABLET · ORAL
LISINOPRILPrescription
LISINOPRIL 30MG · TABLET · ORAL
LISINOPRILPrescription
LISINOPRIL 10MG · TABLET · ORAL
LISINOPRILPrescription
LISINOPRIL 2.5MG · TABLET · ORAL
Approval history
2020-04-27Labeling · Supplement 32 · standardAP
2016-09-08Labeling · Supplement 30 · standardAP
2016-02-24Manufacturing (CMC) · Supplement 13AP
2016-01-04Labeling · Supplement 29 · standardAP
2016-01-04Labeling · Supplement 24 · standardAP
2014-12-11Labeling · Supplement 22 · standardAP
2014-12-11Labeling · Supplement 14AP
2014-12-11Labeling · Supplement 20 · standardAP
2014-12-11Labeling · Supplement 19 · standardAP
2014-12-11Labeling · Supplement 15AP
2014-12-11Labeling · Supplement 18 · standardAP
2008-02-25Labeling · Supplement 10AP
2006-01-23Labeling · Supplement 9AP
2005-08-30Labeling · Supplement 7AP
2004-10-29Labeling · Supplement 6AP
2004-06-09Labeling · Supplement 1AP
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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