LILLY FDA Approval NDA 019693

NDA 019693

LILLY

FDA Drug Application

Application #019693

Application Sponsors

NDA 019693LILLY

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 50MG BASE0DECABIDINDECAINIDE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORALEQ 75MG BASE0DECABIDINDECAINIDE HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORALEQ 100MG BASE0DECABIDINDECAINIDE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1989-12-29STANDARD

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19693
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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