APOTEX INC FDA Approval ANDA 207334

ANDA 207334

APOTEX INC

FDA Drug Application

Application #207334

Documents

Letter2022-08-04

Application Sponsors

ANDA 207334APOTEX INC

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2022-02-23STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207334
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BROMFENAC","activeIngredients":"BROMFENAC","strength":"0.07%","dosageForm":"SOLUTION; OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/23\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-23
        )

)

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