APPLICATION
ANDA076990
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-13
LATEST ACTION
2024-12-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
Approval history
2024-12-09Labeling · Supplement 29 · standardAP
2024-12-09Labeling · Supplement 30 · standardAP
2021-06-07Labeling · Supplement 23 · standardAP
2021-06-07Labeling · Supplement 28 · standardAP
2021-06-07Labeling · Supplement 26 · standardAP
2021-06-07Labeling · Supplement 22 · standardAP
2015-10-23Labeling · Supplement 21 · standardAP
2014-12-05Labeling · Supplement 19 · standardAP
2014-12-05Labeling · Supplement 18 · standardAP
2014-12-05Labeling · Supplement 16 · standardAP
2014-12-05Labeling · Supplement 20 · standardAP
2012-02-28Labeling · Supplement 14AP
2010-08-30Labeling · Supplement 13AP
2010-03-17Labeling · Supplement 12AP
2009-07-09Labeling · Supplement 11AP
2008-10-17Labeling · Supplement 9AP
2008-10-17Labeling · Supplement 8AP
2008-07-07Labeling · Supplement 7AP
2007-10-10Labeling · Supplement 6AP
2006-10-05Labeling · Supplement 5AP
2005-08-09Labeling · Supplement 2AP
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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