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FDA NDA · NDA022148

CYMBALTA

Sponsor: LILLY

APPLICATION
NDA022148
TYPE
NDA
ORIGINAL APPROVAL
2008-06-13
LATEST ACTION
2008-06-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription

Products

CYMBALTAPrescription
DULOXETINE HYDROCHLORIDE EQ 60MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
CYMBALTAPrescription
DULOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
CYMBALTAPrescription
DULOXETINE HYDROCHLORIDE EQ 30MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2008-06-13Type 6 - New Indication (no longer used) · Original · standardLabelAP
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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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