APPLICATION
ANDA075658
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-29
LATEST ACTION
2020-07-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
Approval history
2020-07-20Labeling · Supplement 33 · standardAP
2020-07-20Labeling · Supplement 31 · standardAP
2020-07-20Labeling · Supplement 32 · standardAP
2020-07-20Labeling · Supplement 30 · standardAP
2017-07-12Labeling · Supplement 29 · standardAP
2009-09-28Labeling · Supplement 28AP
2008-09-25Labeling · Supplement 27AP
2008-03-03Labeling · Supplement 26AP
2007-06-29Labeling · Supplement 25AP
2007-06-29Labeling · Supplement 23AP
2006-09-27Labeling · Supplement 22AP
2006-02-28Labeling · Supplement 20AP
2006-02-28Labeling · Supplement 21AP
2005-10-21Labeling · Supplement 19AP
2004-12-06Labeling · Supplement 13AP
2004-12-06Labeling · Supplement 16AP
2004-08-20Labeling · Supplement 11AP
2003-11-13Labeling · Supplement 7AP
2002-11-24Labeling · Supplement 6AP
2002-11-05Manufacturing (CMC) · Supplement 4AP
2002-11-05Manufacturing (CMC) · Supplement 2AP
2002-11-05Labeling · Supplement 3AP
2002-11-05Manufacturing (CMC) · 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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