STORZ FDA Approval NDA 050266

NDA 050266

STORZ

FDA Drug Application

Application #050266

Application Sponsors

NDA 050266STORZ

Marketing Status

Discontinued001

Application Products

001OINTMENT;OPHTHALMIC10MG/GM0ACHROMYCINTETRACYCLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP1957-04-19UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1992-11-18
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1993-01-28

Submissions Property Types

SUPPL2Null0
SUPPL3Null0

CDER Filings

STORZ
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50266
            [companyName] => STORZ
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACHROMYCIN","activeIngredients":"TETRACYCLINE HYDROCHLORIDE","strength":"10MG\/GM","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACHROMYCIN","submission":"TETRACYCLINE HYDROCHLORIDE","actionType":"10MG\/GM","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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