APPLICATION
ANDA075872
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-29
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2023-08-18Labeling · Supplement 35 · standardAP
2023-08-08Labeling · Supplement 34 · standardAP
2021-09-21Labeling · Supplement 32 · standardAP
2021-08-27Labeling · Supplement 27 · standardAP
2021-08-27Labeling · Supplement 25 · standardAP
2017-01-04Labeling · Supplement 21 · standardAP
2016-12-27Labeling · Supplement 20 · standardAP
2014-07-18Labeling · Supplement 18 · standardAP
2014-07-16Labeling · Supplement 17 · standardAP
2014-02-28Labeling · Supplement 15AP
2014-02-28Labeling · Supplement 16AP
2011-01-25Labeling · Supplement 13AP
2010-05-10Labeling · Supplement 14AP
2009-03-23Labeling · Supplement 11AP
2008-12-03Labeling · Supplement 10AP
2008-02-14Labeling · Supplement 7AP
2008-02-14Labeling · Supplement 8AP
2007-04-11Labeling · Supplement 6AP
2006-08-17Labeling · Supplement 5AP
2005-09-13Labeling · Supplement 4AP
2004-09-13Labeling · Supplement 3AP
2003-11-24Labeling · 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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