APPLICATION
ANDA090739
TYPE
ANDA
ORIGINAL APPROVAL
2014-01-08
LATEST ACTION
2019-05-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
DULOXETINE HYDROCHLORIDEPrescription
DULOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
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
2019-05-22Labeling · Supplement 13 · standardAP
2017-04-06Manufacturing (CMC) · Supplement 11AP
2017-04-06Labeling · Supplement 6 · standardAP
2017-04-06Labeling · Supplement 12 · standardAP
2017-04-06Labeling · Supplement 7 · standardAP
2017-04-06Labeling · Supplement 10 · standardAP
2017-04-06Labeling · Supplement 5 · standardAP
2014-09-26Labeling · Supplement 4 · standardAP
2014-09-26Labeling · Supplement 3 · 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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