APPLICATION
ANDA076001
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-29
LATEST ACTION
2024-10-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
Approval history
2024-10-24Labeling · Supplement 54 · standardAP
2024-10-24Labeling · Supplement 60 · standardAP
2024-10-24Labeling · Supplement 50 · standardAP
2020-12-23Labeling · Supplement 43 · standardAP
2020-12-23Labeling · Supplement 48 · standardAP
2020-12-23Labeling · Supplement 46 · standardAP
2016-01-10Labeling · Supplement 40 · standardAP
2016-01-10Labeling · Supplement 30AP
2014-11-17Labeling · Supplement 38 · standardAP
2014-11-17Labeling · Supplement 36 · standardAP
2014-11-17Labeling · Supplement 39 · standardAP
2014-10-17Manufacturing (CMC) · Supplement 35AP
2014-08-19Manufacturing (CMC) · Supplement 37 · unknownAP
2012-02-28Labeling · Supplement 33AP
2012-02-28Labeling · Supplement 32AP
2010-05-19Labeling · Supplement 28AP
2009-09-28Labeling · Supplement 25AP
2008-08-18Labeling · Supplement 22AP
2008-08-18Labeling · Supplement 20AP
2008-01-16Labeling · Supplement 17AP
2008-01-16Labeling · Supplement 15AP
2007-09-28Labeling · Supplement 9AP
2007-05-24Labeling · Supplement 14AP
2006-10-05Labeling · Supplement 13AP
2006-03-02Labeling · Supplement 5AP
2005-04-22Labeling · Supplement 3AP
2005-04-22Labeling · Supplement 4AP
2005-04-22Labeling · Supplement 2AP
2003-11-26Labeling · 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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