APPLICATION
ANDA204597
TYPE
ANDA
ORIGINAL APPROVAL
2015-03-16
LATEST ACTION
2024-01-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
Approval history
2024-01-09Labeling · Supplement 21 · standardAP
2024-01-09Labeling · Supplement 13 · standardAP
2021-03-01Labeling · Supplement 11 · standardAP
2019-10-29Labeling · Supplement 5 · standardAP
2019-10-29Labeling · Supplement 3 · standardAP
2019-10-29Labeling · Supplement 4 · standardAP
2015-03-16UNKNOWN · OriginalAP
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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