APPLICATION
ANDA076287
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-20
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
Approval history
2023-08-18Labeling · Supplement 10 · standardAP
2021-09-20Labeling · Supplement 9 · standardAP
2017-01-04Labeling · Supplement 8 · standardAP
2016-05-05Labeling · Supplement 7 · standardAP
2015-07-31Labeling · Supplement 6 · standardAP
2010-04-22Labeling · Supplement 5AP
2009-07-14Labeling · Supplement 3AP
2009-01-26Labeling · 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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