APPLICATION
ANDA075207
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-30
LATEST ACTION
2024-07-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
Approval history
2024-07-11Labeling · Supplement 26 · standardAP
2019-10-29Labeling · Supplement 24 · standardAP
2011-01-15Manufacturing (CMC) · Supplement 23AP
2009-12-10Labeling · Supplement 20AP
2009-07-09Labeling · Supplement 17AP
2008-02-11Labeling · Supplement 13AP
2008-02-11Labeling · Supplement 14AP
2007-05-25Labeling · Supplement 10TA
2007-05-25Manufacturing (CMC) · Supplement 9AP
2007-02-22Labeling · Supplement 11AP
2007-02-22Labeling · Supplement 12AP
2006-08-17Labeling · Supplement 6AP
2006-01-31Labeling · Supplement 5AP
2005-04-22Labeling · Supplement 4AP
2005-04-22Labeling · Supplement 3AP
2004-09-13Labeling · Supplement 2AP
2003-11-14Labeling · 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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