APPLICATION
ANDA075920
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-29
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 19 · standardAP
2021-09-21Labeling · Supplement 18 · standardAP
2021-08-30Labeling · Supplement 17 · standardAP
2017-01-04Labeling · Supplement 16 · standardAP
2014-07-17Labeling · Supplement 15 · standardAP
2009-09-28Labeling · Supplement 14AP
2008-09-24Labeling · Supplement 13AP
2008-03-03Labeling · Supplement 12AP
2007-06-29Labeling · Supplement 11AP
2007-06-29Labeling · Supplement 10AP
2006-09-27Labeling · Supplement 9AP
2006-02-28Labeling · Supplement 8AP
2006-02-28Labeling · Supplement 7AP
2005-10-21Labeling · Supplement 6AP
2004-12-06Labeling · Supplement 4AP
2004-12-06Labeling · Supplement 2AP
2003-11-13Labeling · 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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