APOTEX INC FDA Approval ANDA 091308

ANDA 091308

APOTEX INC

FDA Drug Application

Application #091308

Application Sponsors

ANDA 091308APOTEX INC

Marketing Status

Prescription001

Application Products

001CREAM;TOPICAL5%0IMIQUIMODIMIQUIMOD

FDA Submissions

ORIG1AP2012-04-06

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91308
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMIQUIMOD","activeIngredients":"IMIQUIMOD","strength":"5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IMIQUIMOD","submission":"IMIQUIMOD","actionType":"5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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