APPLICATION
ANDA090783
TYPE
ANDA
ORIGINAL APPROVAL
2013-12-11
LATEST ACTION
2024-10-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued
Products
DULOXETINE HYDROCHLORIDEDiscontinued
DULOXETINE HYDROCHLORIDE EQ 30MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEDiscontinued
DULOXETINE HYDROCHLORIDE EQ 60MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEDiscontinued
DULOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2024-10-10Labeling · Supplement 8 · standardAP
2024-10-10Labeling · Supplement 14 · standardAP
2024-10-10Labeling · Supplement 12 · standardAP
2024-10-10Labeling · Supplement 10 · standardAP
2024-10-10Labeling · Supplement 17 · standardAP
2024-10-10Labeling · Supplement 7 · standardAP
2024-10-10Labeling · Supplement 5 · standardAP
2014-12-13Labeling · 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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