MEDA PHARMS FDA Approval NDA 018307

NDA 018307

MEDA PHARMS

FDA Drug Application

Application #018307

Application Sponsors

NDA 018307MEDA PHARMS

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL130MG0THYRO-BLOCKPOTASSIUM IODIDE

FDA Submissions

ORIG1AP1979-11-09
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1985-07-16
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1989-01-24
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1989-01-24
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1992-08-10
BIOEQUIV; BioequivalenceSUPPL13AP1991-02-21
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2000-09-21

Submissions Property Types

ORIG1Null0
SUPPL6Null0
SUPPL9Null0
SUPPL10Null0
SUPPL12Null0
SUPPL13Null0
SUPPL17Null0

CDER Filings

MEDA PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18307
            [companyName] => MEDA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"THYRO-BLOCK","activeIngredients":"POTASSIUM IODIDE","strength":"130MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THYRO-BLOCK","submission":"POTASSIUM IODIDE","actionType":"130MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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