LILLY FDA Approval NDA 009238

NDA 009238

LILLY

FDA Drug Application

Application #009238

Application Sponsors

NDA 009238LILLY

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTION50MG/ML0PROGESTERONEPROGESTERONE
002INJECTABLE;INJECTION25MG/ML0PROGESTERONEPROGESTERONE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1974-11-01STANDARD
LABELING; LabelingSUPPL7AP2001-09-17
EFFICACY; EfficacySUPPL8AP2001-09-17
EFFICACY; EfficacySUPPL11AP2001-09-17
LABELING; LabelingSUPPL12AP1981-03-09
LABELING; LabelingSUPPL13AP1984-11-16

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 9238
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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