APPLICATION
ANDA076015
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-30
LATEST ACTION
2023-08-21
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML · SOLUTION · ORAL
Approval history
2023-08-21Labeling · Supplement 23 · standardAP
2021-09-21Labeling · Supplement 22 · standardAP
2021-08-27Labeling · Supplement 16 · standardAP
2021-08-27Labeling · Supplement 20 · standardAP
2017-01-04Labeling · Supplement 13 · standardAP
2016-12-27Labeling · Supplement 12 · standardAP
2014-09-11Labeling · Supplement 11 · standardAP
2014-08-11Labeling · Supplement 10 · standardAP
2013-07-26Labeling · Supplement 8AP
2012-07-31Labeling · Supplement 9AP
2010-09-20Labeling · Supplement 7AP
2009-12-28Labeling · Supplement 6AP
2009-01-02Labeling · Supplement 4AP
2006-01-31Labeling · 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.
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