APPLICATION
ANDA075525
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-27
LATEST ACTION
2025-05-05
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML · SOLUTION · ORAL
Approval history
2025-05-05Manufacturing (CMC) · Supplement 7 · unknownAP
2021-09-20Labeling · Supplement 6 · standardAP
2021-08-31Labeling · Supplement 4 · standardAP
2017-01-04Labeling · Supplement 3 · standardAP
2016-12-27Labeling · Supplement 2 · standardAP
2014-09-11Labeling · Supplement 1 · standardAP
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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