LILLY FDA Approval ANDA 061896

ANDA 061896

LILLY

FDA Drug Application

Application #061896

Application Sponsors

ANDA 061896LILLY

Marketing Status

Discontinued001

Application Products

001TABLET;ORALEQ 500MG BASE0ILOSONEERYTHROMYCIN ESTOLATE

FDA Submissions

ORIG1AP1975-01-03
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1990-04-10
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1990-04-10
LABELING; LabelingSUPPL9AP1991-10-23
LABELING; LabelingSUPPL10AP1991-09-05
LABELING; LabelingSUPPL11AP1990-04-16
LABELING; LabelingSUPPL12AP1991-01-14
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1992-01-27
LABELING; LabelingSUPPL19AP1997-07-22

Submissions Property Types

ORIG1Null0
SUPPL6Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL19Null0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61896
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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