APPLICATION
ANDA206653
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-18
LATEST ACTION
2023-05-02
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
2023-05-02Labeling · Supplement 10 · standardAP
2023-05-02Labeling · Supplement 8 · standardAP
2023-05-02Labeling · Supplement 9 · standardAP
2023-05-02Labeling · Supplement 7 · standardAP
2017-05-18UNKNOWN · Original · 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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