APPLICATION
ANDA208706
TYPE
ANDA
ORIGINAL APPROVAL
2017-01-06
LATEST ACTION
2022-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 60MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 30MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2022-07-29Labeling · Supplement 51 · standardAP
2022-07-29Labeling · Supplement 29 · standardAP
2022-07-29Labeling · Supplement 25 · standardAP
2022-07-29Labeling · Supplement 3 · standardAP
2022-07-29Labeling · Supplement 1 · standardAP
2022-07-29Labeling · Supplement 42 · standardAP
2022-07-29Labeling · Supplement 6 · standardAP
2022-07-26Manufacturing (CMC) · Supplement 49 · unknownAP
2017-01-06UNKNOWN · 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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