LILLY FDA Approval ANDA 061897

ANDA 061897

LILLY

FDA Drug Application

Application #061897

Application Sponsors

ANDA 061897LILLY

Marketing Status

Discontinued001
Discontinued002

Application Products

001CAPSULE;ORALEQ 125MG BASE0ILOSONEERYTHROMYCIN ESTOLATE
002CAPSULE;ORALEQ 250MG BASE0ILOSONEERYTHROMYCIN ESTOLATE

FDA Submissions

ORIG1AP1975-01-06
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1990-04-10
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1990-04-10
LABELING; LabelingSUPPL13AP1991-10-23
LABELING; LabelingSUPPL14AP1991-09-05
LABELING; LabelingSUPPL15AP1991-01-14
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1992-01-27
LABELING; LabelingSUPPL22AP1997-07-22

Submissions Property Types

ORIG1Null0
SUPPL10Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL22Null0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61897
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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