APPLICATION
ANDA200151
TYPE
ANDA
ORIGINAL APPROVAL
2014-02-03
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SELFEMRADiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
SELFEMRADiscontinued
FLUOXETINE HYDROCHLORIDE EQ 15MG BASE · TABLET · ORAL
SELFEMRADiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
Approval history
2023-08-18Labeling · Supplement 9 · standardAP
2023-08-09Labeling · Supplement 8 · standardAP
2021-09-21Labeling · Supplement 7 · standardAP
2020-05-20Labeling · Supplement 4 · standardAP
2017-01-04Labeling · Supplement 3 · standardAP
2016-12-21Labeling · Supplement 2 · standardAP
2014-07-18Labeling · Supplement 1 · standardAP
2014-02-03OriginalAP
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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