APPLICATION
ANDA075810
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-01
LATEST ACTION
2014-11-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2014-11-17Labeling · Supplement 3 · standardAP
2003-11-26Labeling · Supplement 2AP
2002-09-26Manufacturing (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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