FDA ANDA · ANDA218875
ATOMOXETINE
Sponsor: PHARMAZONE
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APPLICATION
ANDA218875
TYPE
ANDA
ORIGINAL APPROVAL
2026-06-16
LATEST ACTION
2026-09-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
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
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
Approval history
2026-09-30Labeling · Supplement 2 · standardAP
2026-06-16UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →