EI INC FDA Approval ANDA 078176

ANDA 078176

EI INC

FDA Drug Application

Application #078176

Application Sponsors

ANDA 078176EI INC

Marketing Status

Over-the-counter001

Application Products

001SOLUTION;TOPICAL2%0THEROXIDILMINOXIDIL

FDA Submissions

ORIG1AP2007-11-09
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2016-07-21

Submissions Property Types

SUPPL6Null15

CDER Filings

EI INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78176
            [companyName] => EI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEROXIDIL","activeIngredients":"MINOXIDIL","strength":"2%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THEROXIDIL","submission":"MINOXIDIL","actionType":"2%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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