APOTEX INC FDA Approval ANDA 214862

ANDA 214862

APOTEX INC

FDA Drug Application

Application #214862

Application Sponsors

ANDA 214862APOTEX INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

002TABLET; ORAL10mg0OBETICHOLIC ACIDOBETICHOLIC ACID

FDA Submissions

UNKNOWN; ORIG1TA2022-06-14STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214862
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OBETICHOLIC ACID","activeIngredients":"OBETICHOLIC ACID","strength":"5mg","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"OBETICHOLIC ACID","activeIngredients":"OBETICHOLIC ACID","strength":"10mg","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/14\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-14
        )

)

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