APPLICATION
ANDA090694
TYPE
ANDA
ORIGINAL APPROVAL
2013-12-11
LATEST ACTION
2025-03-10
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 40MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 60MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2025-03-10Labeling · Supplement 18 · standardAP
2025-03-10Labeling · Supplement 16 · standardAP
2025-03-10Labeling · Supplement 10 · standardAP
2025-03-10Labeling · Supplement 25 · standardAP
2025-03-10Labeling · Supplement 23 · standardAP
2025-03-10Labeling · Supplement 21 · standardAP
2025-03-10Labeling · Supplement 13 · standardAP
2025-03-10Labeling · Supplement 8 · standardAP
2025-03-10Labeling · Supplement 11 · standardAP
2015-12-02Labeling · Supplement 7 · standardAP
2015-12-02Labeling · Supplement 5 · standardAP
2015-12-02Labeling · Supplement 3 · standardAP
2015-12-02Labeling · Supplement 6 · standardAP
2015-12-02Labeling · Supplement 4 · 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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