NORWICH FDA Approval ANDA 214370

ANDA 214370

NORWICH

FDA Drug Application

Application #214370

Application Sponsors

ANDA 214370NORWICH

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2022-09-02STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

NORWICH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214370
            [companyName] => NORWICH
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIFAXIMIN","activeIngredients":"RIFAXIMIN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/02\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-02
        )

)

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