APPLICATION
ANDA075514
TYPE
ANDA
ORIGINAL APPROVAL
2002-08-29
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML · SOLUTION · ORAL
Approval history
2023-08-18Labeling · Supplement 17 · standardAP
2021-09-21Labeling · Supplement 16 · standardAP
2021-08-30Labeling · Supplement 15 · standardAP
2017-01-04Labeling · Supplement 14 · standardAP
2016-12-27Labeling · Supplement 13 · standardAP
2014-12-23Labeling · Supplement 12 · standardAP
2010-05-06Labeling · Supplement 11AP
2009-08-21Labeling · Supplement 9AP
2008-06-03Labeling · Supplement 8AP
2008-06-03Labeling · Supplement 7AP
2007-10-10Labeling · Supplement 6AP
2007-05-09Labeling · Supplement 5AP
2006-03-02Labeling · Supplement 3AP
2005-08-31Labeling · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.