APPLICATION
ANDA075034
TYPE
ANDA
ORIGINAL APPROVAL
1998-07-20
LATEST ACTION
2021-04-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GEMFIBROZILDiscontinued
GEMFIBROZIL 600MG · TABLET · ORAL
Approval history
2021-04-30Labeling · Supplement 31 · standardAP
2019-02-19Labeling · Supplement 29 · standardAP
2017-09-18Labeling · Supplement 28 · standardAP
2016-10-03Labeling · Supplement 27 · standardAP
2015-05-08Labeling · Supplement 25 · standardAP
2015-05-08Labeling · Supplement 26 · standardAP
2011-03-14Labeling · Supplement 24AP
2010-11-22Labeling · Supplement 23AP
2006-12-21Labeling · Supplement 15AP
2005-11-04Labeling · Supplement 11AP
2005-08-01Labeling · Supplement 12AP
2002-03-25Labeling · Supplement 3AP
2002-01-31Manufacturing (CMC) · Supplement 2AP
2001-07-26Labeling · 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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