APPLICATION
ANDA213265
TYPE
ANDA
ORIGINAL APPROVAL
2020-06-10
LATEST ACTION
2026-01-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 60MG BASE · TABLET · ORAL
Approval history
2026-01-15Manufacturing (CMC) · Supplement 5 · unknownAP
2024-05-02Labeling · Supplement 3 · standardAP
2024-05-02Labeling · Supplement 4 · standardAP
2020-06-10UNKNOWN · Original · 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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