APPLICATION
ANDA090223
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-19
LATEST ACTION
2023-12-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
Approval history
2023-12-19Labeling · Supplement 29 · standardAP
2023-12-19Labeling · Supplement 31 · standardAP
2021-01-21Labeling · Supplement 10 · standardAP
2021-01-21Labeling · Supplement 25 · standardAP
2016-01-12Labeling · Supplement 9 · standardAP
2016-01-12Labeling · Supplement 7 · standardAP
2012-02-28Labeling · Supplement 3AP
2012-02-28Labeling · Supplement 4AP
2010-03-22Labeling · Supplement 1AP
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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