APPLICATION
ANDA078983
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-30
LATEST ACTION
2023-01-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE · CAPSULE · ORAL
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE · CAPSULE · ORAL
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE · CAPSULE · ORAL
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
ATOMOXETINE HYDROCHLORIDEPrescription
ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE · CAPSULE · ORAL
Approval history
2023-01-19Labeling · Supplement 5 · standardAP
2021-03-09Labeling · Supplement 2 · 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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