ALCON FDA Approval ANDA 061648

ANDA 061648

ALCON

FDA Drug Application

Application #061648

Application Sponsors

ANDA 061648ALCON

Marketing Status

Discontinued001

Application Products

001OINTMENT;OPHTHALMIC1%0ECONOCHLORCHLORAMPHENICOL

FDA Submissions

ORIG1AP1974-05-14
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1999-03-23
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2000-01-18

Submissions Property Types

SUPPL5Null0
SUPPL6Null0

CDER Filings

ALCON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61648
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"ECONOCHLOR","activeIngredients":"CHLORAMPHENICOL","strength":"1%","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ECONOCHLOR","submission":"CHLORAMPHENICOL","actionType":"1%","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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