APPLICATION
ANDA202045
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-11
LATEST ACTION
2024-01-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued
Products
DULOXETINE HYDROCHLORIDEDiscontinued
DULOXETINE HYDROCHLORIDE EQ 60MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEDiscontinued
DULOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEDiscontinued
DULOXETINE HYDROCHLORIDE EQ 30MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2024-01-31Labeling · Supplement 17 · standardAP
2023-05-02Labeling · Supplement 13 · standardAP
2023-05-02Labeling · Supplement 11 · standardAP
2023-05-02Labeling · Supplement 16 · standardAP
2023-05-02Labeling · Supplement 14 · standardAP
2017-07-10Labeling · Supplement 2 · standardAP
2017-07-10Labeling · Supplement 9 · standardAP
2017-07-10Labeling · Supplement 5 · standardAP
2017-07-10Labeling · Supplement 10 · standardAP
2017-07-10Labeling · Supplement 6 · standardAP
2014-06-11OriginalAP
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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