NDA 022516

LILLY

FDA Drug Application

Application #022516

Documents

• Label: 2010-11-05
• Review: 2011-09-16
• Letter: 2010-11-09
• Summary Review: 2010-12-01

Application Sponsors

NDA 022516

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

2010-11-04

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22516
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)