AMNEAL PHARMS NY FDA Approval ANDA 214810

ANDA 214810

AMNEAL PHARMS NY

FDA Drug Application

Application #214810

Documents

Letter2021-10-08

Application Sponsors

ANDA 214810AMNEAL PHARMS NY

Marketing Status

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

FDA Submissions

UNKNOWN; ORIG1TA2021-09-08STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

AMNEAL PHARMS NY
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214810
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"OBETICHOLIC","activeIngredients":"OBETICHOLIC ACID","strength":"5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"OBETICHOLIC","activeIngredients":"OBETICHOLIC ACID","strength":"10MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/08\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214810Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-08
        )

)

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