APPLICATION
ANDA077469
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-17
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
Approval history
2023-08-18Labeling · Supplement 18 · standardAP
2023-08-15Labeling · Supplement 16 · standardAP
2023-08-15Labeling · Supplement 17 · standardAP
2017-01-04Labeling · Supplement 13 · standardAP
2016-05-05Labeling · Supplement 12 · standardAP
2015-07-31Labeling · Supplement 11 · standardAP
2009-12-15Labeling · Supplement 5AP
2009-12-15Labeling · Supplement 2AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.