LILLY FDA Approval ANDA 062739

ANDA 062739

LILLY

FDA Drug Application

Application #062739

Application Sponsors

ANDA 062739LILLY

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTION1GM/VIAL0TAZIDIME IN PLASTIC CONTAINERCEFTAZIDIME
002INJECTABLE;INJECTION2GM/VIAL0TAZIDIME IN PLASTIC CONTAINERCEFTAZIDIME

FDA Submissions

ORIG1AP1986-07-10
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1987-01-23
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1986-10-30
LABELING; LabelingSUPPL4AP1992-02-14
LABELING; LabelingSUPPL5AP1992-02-14
LABELING; LabelingSUPPL6AP2007-12-07
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1993-04-02
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1993-10-18
LABELING; LabelingSUPPL9AP1996-02-26
LABELING; LabelingSUPPL10AP1996-07-15

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL7Null0
SUPPL8Null0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62739
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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