ALKEM LABS LTD FDA Approval ANDA 213782

ANDA 213782

ALKEM LABS LTD

FDA Drug Application

Application #213782

Documents

Letter2021-10-08

Application Sponsors

ANDA 213782ALKEM LABS LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004
None (Tentative Approval)005
None (Tentative Approval)006

Application Products

001TABLET;ORAL0.25MG0BREXPIPRAZOLEBREXPIPRAZOLE

FDA Submissions

UNKNOWN; ORIG1TA2021-09-27STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213782
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/27\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-27
        )

)

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