APPLICATION
ANDA077849
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-09
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML · SOLUTION · ORAL
Approval history
2023-08-18Labeling · Supplement 17 · standardAP
2021-09-21Labeling · Supplement 13 · standardAP
2021-09-07Labeling · Supplement 11 · standardAP
2021-09-07Labeling · Supplement 12 · standardAP
2017-01-04Labeling · Supplement 10 · standardAP
2016-12-27Labeling · Supplement 9 · standardAP
2014-07-18Labeling · Supplement 8 · standardAP
2014-07-16Labeling · Supplement 6 · standardAP
2009-03-11Labeling · Supplement 4AP
2009-03-11Labeling · Supplement 3AP
2008-05-29Labeling · Supplement 2AP
2007-10-10Labeling · Supplement 1AP
2007-02-09OriginalAP
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.