APPLICATION
ANDA201336
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-01
LATEST ACTION
2020-07-20
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
2020-07-20Labeling · Supplement 2 · standardAP
2020-07-20Labeling · Supplement 5 · standardAP
2020-07-20Labeling · Supplement 3 · standardAP
2020-07-20Labeling · Supplement 1 · standardAP
2020-07-20Labeling · Supplement 4 · standardAP
2012-10-01Not Applicable · 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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