APPLICATION
ANDA075465
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-29
LATEST ACTION
2023-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
Approval history
2023-11-21Labeling · Supplement 21 · standardAP
2014-10-21Labeling · Supplement 19 · standardAP
2012-04-19Labeling · Supplement 18AP
2011-11-22Labeling · Supplement 17AP
2009-08-21Labeling · Supplement 15AP
2009-08-21Labeling · Supplement 16AP
2008-12-15Labeling · Supplement 14AP
2008-04-24Labeling · Supplement 13AP
2006-11-17Labeling · Supplement 11AP
2006-11-17Labeling · Supplement 12AP
2006-03-02Labeling · Supplement 10AP
2005-06-07Labeling · Supplement 8AP
2002-11-19Labeling · 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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