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FDA ANDA · ANDA077622

LISINOPRIL

Sponsor: AUROBINDO

APPLICATION
ANDA077622
TYPE
ANDA
ORIGINAL APPROVAL
2006-02-22
LATEST ACTION
2020-05-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LISINOPRILPrescription
LISINOPRIL 30MG · TABLET · ORAL
LISINOPRILPrescription
LISINOPRIL 10MG · TABLET · ORAL
LISINOPRILPrescription
LISINOPRIL 2.5MG · TABLET · ORAL
LISINOPRILPrescription
LISINOPRIL 40MG · TABLET · ORAL
LISINOPRILPrescription
LISINOPRIL 20MG · TABLET · ORAL
LISINOPRILPrescription
LISINOPRIL 5MG · TABLET · ORAL

Approval history

2020-05-13Labeling · Supplement 25 · standardAP
2016-09-13Labeling · Supplement 24 · standardAP
2016-04-07Labeling · Supplement 22 · standardAP
2015-08-25Labeling · Supplement 20 · standardAP
2015-08-25Labeling · Supplement 19 · standardAP
2015-08-25Labeling · Supplement 21 · standardAP
2014-06-13Manufacturing (CMC) · Supplement 11AP
2013-08-22Labeling · Supplement 18 · standardAP
2013-08-20Labeling · Supplement 17 · standardAP
2009-12-04Labeling · Supplement 5AP
2008-01-28Labeling · Supplement 2AP
2007-02-06Labeling · Supplement 1AP
2006-02-22OriginalAP
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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