LILLY FDA Approval NDA 012772

NDA 012772

LILLY

FDA Drug Application

Application #012772

Application Sponsors

NDA 012772LILLY

Marketing Status

Discontinued005
Discontinued006

Application Products

005TABLET;ORAL1MG0HALDRONEPARAMETHASONE ACETATE
006TABLET;ORAL2MG0HALDRONEPARAMETHASONE ACETATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1961-04-17STANDARD
LABELING; LabelingSUPPL4AP1977-08-22
LABELING; LabelingSUPPL5AP1980-03-19
LABELING; LabelingSUPPL7AP1986-05-27
LABELING; LabelingSUPPL8AP1997-01-09
LABELING; LabelingSUPPL9AP1997-01-09

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12772
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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