APPLICATION
ANDA076458
TYPE
ANDA
ORIGINAL APPROVAL
2004-05-14
LATEST ACTION
2025-08-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML · SOLUTION · ORAL
Approval history
2025-08-13Labeling · Supplement 12 · standardAP
2023-08-18Labeling · Supplement 11 · standardAP
2021-09-21Labeling · Supplement 10 · standardAP
2017-01-04Labeling · Supplement 8 · standardAP
2015-01-12Labeling · Supplement 7 · standardAP
2009-09-28Labeling · Supplement 6AP
2008-08-18Labeling · Supplement 5AP
2008-02-14Labeling · Supplement 4AP
2007-08-02Labeling · Supplement 3AP
2007-08-02Labeling · Supplement 2AP
2005-09-15Labeling · 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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