ACCORD HLTHCARE INC FDA Approval ANDA 213788

ANDA 213788

ACCORD HLTHCARE INC

FDA Drug Application

Application #213788

Documents

Letter2021-09-02

Application Sponsors

ANDA 213788ACCORD HLTHCARE INC

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; ORIG1TA2021-08-17STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ACCORD HLTHCARE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213788
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"0.25MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"0.5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"1MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"2MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"3MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"4MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213788Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-17
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.