APPLICATION
ANDA210935
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-20
LATEST ACTION
2026-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2026-06-17Manufacturing (CMC) · Supplement 11 · unknownAP
2023-08-18Labeling · Supplement 9 · standardAP
2021-09-21Labeling · Supplement 4 · standardAP
2019-03-20UNKNOWN · 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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