APPLICATION
ANDA206937
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-21
LATEST ACTION
2023-08-18
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
2023-08-18Labeling · Supplement 8 · standardAP
2023-08-10Labeling · Supplement 7 · standardAP
2021-09-21Labeling · Supplement 6 · standardAP
2021-09-02Labeling · Supplement 3 · standardAP
2016-10-21UNKNOWN · 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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