APPLICATION
ANDA202949
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-09
LATEST ACTION
2026-04-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 30MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 60MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2026-04-09Manufacturing (CMC) · Supplement 26 · unknownAP
2024-02-08Labeling · Supplement 19 · standardAP
2024-02-08Labeling · Supplement 8 · standardAP
2024-02-08Labeling · Supplement 23 · standardAP
2024-02-08Labeling · Supplement 4 · standardAP
2024-02-08Labeling · Supplement 11 · standardAP
2024-02-08Labeling · Supplement 2 · standardAP
2024-02-08Labeling · Supplement 9 · standardAP
2024-02-08Labeling · Supplement 16 · standardAP
2024-02-08Labeling · Supplement 3 · standardAP
2014-06-09UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.