ROERIG FDA Approval NDA 016818

NDA 016818

ROERIG

FDA Drug Application

Application #016818

Application Sponsors

NDA 016818ROERIG

Marketing Status

Discontinued006

Application Products

006SUPPOSITORY;RECTALEQ 100MG BASE0EMETE-CONBENZQUINAMIDE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1978-09-27STANDARD

CDER Filings

ROERIG
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16818
            [companyName] => ROERIG
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMETE-CON","activeIngredients":"BENZQUINAMIDE HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EMETE-CON","submission":"BENZQUINAMIDE HYDROCHLORIDE","actionType":"EQ 100MG BASE","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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