APPLICATION
ANDA075506
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-02
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML · SOLUTION · ORAL
Approval history
2023-08-18Labeling · Supplement 26 · standardAP
2021-09-21Labeling · Supplement 25 · standardAP
2021-08-30Labeling · Supplement 24 · standardAP
2017-01-04Labeling · Supplement 23 · standardAP
2016-12-27Labeling · Supplement 21 · standardAP
2014-07-17Labeling · Supplement 20 · standardAP
2012-07-31Labeling · Supplement 16AP
2012-07-31Labeling · Supplement 17AP
2010-05-06Labeling · Supplement 15AP
2009-07-09Labeling · Supplement 14AP
2008-10-22Labeling · Supplement 13AP
2008-02-14Labeling · Supplement 10AP
2008-02-14Labeling · Supplement 11AP
2007-03-28Labeling · Supplement 8AP
2006-08-17Labeling · Supplement 7AP
2006-01-31Labeling · Supplement 5AP
2006-01-31Labeling · Supplement 6AP
2004-09-13Labeling · Supplement 3AP
2003-11-24Labeling · 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.
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