APPLICATION
ANDA074256
TYPE
ANDA
ORIGINAL APPROVAL
1993-10-31
LATEST ACTION
2017-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GEMFIBROZILDiscontinued
GEMFIBROZIL 600MG · TABLET · ORAL
Approval history
2017-09-18Labeling · Supplement 43 · standardAP
2016-10-03Labeling · Supplement 41 · standardAP
2015-04-29Labeling · Supplement 38 · standardAP
2015-04-29Labeling · Supplement 39 · standardAP
2011-02-28Labeling · Supplement 32AP
2010-01-12Labeling · Supplement 31AP
2009-03-26Labeling · Supplement 28AP
2005-01-06Labeling · Supplement 24AP
2002-04-11Labeling · Supplement 19AP
2000-07-07Manufacturing (CMC) · Supplement 15AP
2000-01-10Manufacturing (CMC) · Supplement 16AP
1999-12-02Manufacturing (CMC) · Supplement 17AP
1999-12-02Manufacturing (CMC) · Supplement 18AP
1999-02-12Manufacturing (CMC) · Supplement 8AP
1999-02-12Manufacturing (CMC) · Supplement 7AP
1999-01-08Manufacturing (CMC) · Supplement 6AP
1998-05-28Manufacturing (CMC) · Supplement 5AP
1997-11-07Manufacturing (CMC) · Supplement 4AP
1996-12-18Manufacturing (CMC) · Supplement 3AP
1996-09-13Manufacturing (CMC) · Supplement 2AP
1996-02-28Manufacturing (CMC) · Supplement 1AP
1993-10-31OriginalAP
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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