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FDA NDA · NDA022516

CYMBALTA

Sponsor: LILLY

APPLICATION
NDA022516
TYPE
NDA
ORIGINAL APPROVAL
2010-11-04
LATEST ACTION
2010-11-04
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

2010-11-04Type 6 - New Indication (no longer used) · Original · standardSummary ReviewAP
VIEW ON DRUGS@FDA ↗

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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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