AMERICAN REGENT INC FDA Approval NDA 209376

NDA 209376

AMERICAN REGENT INC

FDA Drug Application

Application #209376

Documents

Label2020-07-06
Letter2020-07-07

Application Sponsors

NDA 209376AMERICAN REGENT INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1ML2TRALEMENTTRACE ELEMENTS

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2020-07-02STANDARD

Submissions Property Types

ORIG1Null40

TE Codes

001PrescriptionTBD

CDER Filings

AMERICAN REGENT INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209376
            [companyName] => AMERICAN REGENT INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRALEMENT","activeIngredients":"TRACE ELEMENTS","strength":"1ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"07\/02\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209376s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209376s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209376Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-02
        )

)

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