SCHIFF AND CO FDA Approval NDA 050653

NDA 050653

SCHIFF AND CO

FDA Drug Application

Application #050653

Application Sponsors

NDA 050653SCHIFF AND CO

Marketing Status

Discontinued001

Application Products

001FIBER, EXTENDED RELEASE;PERIODONTAL12.7MG/FIBER0ACTISITETETRACYCLINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1994-03-25STANDARD

Submissions Property Types

SUPPL1Null0

CDER Filings

SCHIFF AND CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50653
            [companyName] => SCHIFF AND CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACTISITE","activeIngredients":"TETRACYCLINE HYDROCHLORIDE","strength":"12.7MG\/FIBER","dosageForm":"FIBER, EXTENDED RELEASE;PERIODONTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACTISITE","submission":"TETRACYCLINE HYDROCHLORIDE","actionType":"12.7MG\/FIBER","submissionClassification":"FIBER, EXTENDED RELEASE;PERIODONTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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