APPLICATION
ANDA204343
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-03
LATEST ACTION
2025-02-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 60MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 30MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2025-02-18Labeling · Supplement 12 · standardAP
2025-02-18Labeling · Supplement 19 · standardAP
2020-12-30Manufacturing (CMC) · Supplement 4 · unknownAP
2020-12-30Labeling · Supplement 7 · standardAP
2020-12-30Labeling · Supplement 3 · standardAP
2018-07-19Labeling · Supplement 1 · standardAP
2016-08-03UNKNOWN · 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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