NDA 022148

LILLY

FDA Drug Application

Application #022148

Documents

• Letter: 2008-06-20
• Label: 2008-06-18
• Review: 2008-09-05
• Summary Review: 2008-08-20

Application Sponsors

NDA 022148

LILLY

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

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
003	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

2008-06-13

STANDARD

CDER Filings

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            [ApplNo] => 22148
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)