APPLICATION
ANDA075452
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-29
LATEST ACTION
2021-04-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
Approval history
2021-04-19Labeling · Supplement 44 · standardAP
2021-04-19Labeling · Supplement 39 · standardAP
2021-04-19Labeling · Supplement 41 · standardAP
2016-03-03Labeling · Supplement 36 · standardAP
2016-03-03Labeling · Supplement 34 · standardAP
2016-03-03Labeling · Supplement 37 · standardAP
2016-03-03Labeling · Supplement 33 · standardAP
2016-03-03Labeling · Supplement 31 · standardAP
2012-01-31Labeling · Supplement 28AP
2012-01-31Labeling · Supplement 30AP
2010-05-24Labeling · Supplement 24AP
2009-03-30Labeling · Supplement 23AP
2008-10-22Labeling · Supplement 22AP
2008-08-11Labeling · Supplement 19AP
2008-04-17Labeling · Supplement 17AP
2007-08-02Labeling · Supplement 16AP
2007-08-02Labeling · Supplement 14AP
2006-08-17Labeling · Supplement 11AP
2006-01-31Labeling · Supplement 6AP
2006-01-31Labeling · Supplement 7AP
2004-09-13Labeling · Supplement 5AP
2003-11-26Labeling · Supplement 2AP
2002-09-05Manufacturing (CMC) · 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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