APPLICATION
ANDA211477
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-21
LATEST ACTION
2024-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 60MG BASE · TABLET · ORAL
Approval history
2024-08-29Labeling · Supplement 3 · standardAP
2024-08-29Labeling · Supplement 2 · standardAP
2018-11-21UNKNOWN · 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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