APOTEX FDA Approval ANDA 207605

ANDA 207605

APOTEX

FDA Drug Application

Application #207605

Documents

Letter2020-06-04

Application Sponsors

ANDA 207605APOTEX

Marketing Status

Prescription001

Application Products

001TABLET;ORAL30MG0TOLVAPTANTOLVAPTAN

FDA Submissions

UNKNOWN; ORIG1AP2020-05-19STANDARD
UNKNOWN; ORIG2TA2020-05-19STANDARD

Submissions Property Types

ORIG1Null7
ORIG2Null31

TE Codes

001PrescriptionAB

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207605
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLVAPTAN","activeIngredients":"TOLVAPTAN","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2020","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207605Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-19
        )

)

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