NDA 021733

LILLY

FDA Drug Application

Application #021733

Documents

• Label: 2004-09-07
• Review: 2005-12-06
• Letter: 2004-09-07
• Other Important Information from FDA: 2005-07-29

Application Sponsors

NDA 021733

LILLY

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 004

Application Products

001	CAPSULE, DELAYED REL PELLETS; ORAL	EQ 20MG BASE	0	CYMBALTA	DULOXETINE HYDROCHLORIDE
002	CAPSULE, DELAYED REL PELLETS; ORAL	EQ 30MG BASE	0	CYMBALTA	DULOXETINE HYDROCHLORIDE
004	CAPSULE, DELAYED REL PELLETS; ORAL	EQ 60MG BASE	0	CYMBALTA	DULOXETINE HYDROCHLORIDE

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2004-09-03

PRIORITY

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 21733
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)