LILLY FDA Approval ANDA 061894

ANDA 061894

LILLY

FDA Drug Application

Application #061894

Application Sponsors

ANDA 061894LILLY

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001SUSPENSION;ORALEQ 125MG BASE/5ML0ILOSONEERYTHROMYCIN ESTOLATE
002SUSPENSION;ORALEQ 250MG BASE/5ML0ILOSONEERYTHROMYCIN ESTOLATE
003SUSPENSION/DROPS;ORALEQ 100MG BASE/ML0ILOSONEERYTHROMYCIN ESTOLATE

FDA Submissions

ORIG1AP1975-01-07
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1990-04-10
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1990-04-10
LABELING; LabelingSUPPL9AP1991-11-13
LABELING; LabelingSUPPL10AP1991-09-05
LABELING; LabelingSUPPL11AP1990-04-16
LABELING; LabelingSUPPL12AP1991-01-14
LABELING; LabelingSUPPL13AP1991-11-13
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1992-01-27
LABELING; LabelingSUPPL19AP1997-07-22

Submissions Property Types

ORIG1Null0
SUPPL6Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL19Null0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61894
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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