SCIEGEN PHARMS INC FDA Approval ANDA 204038

ANDA 204038

SCIEGEN PHARMS INC

FDA Drug Application

Application #204038

Application Sponsors

ANDA 204038SCIEGEN PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL40MG0VALSARTANVALSARTAN
002TABLET;ORAL80MG0VALSARTANVALSARTAN
003TABLET;ORAL160MG0VALSARTANVALSARTAN
004TABLET;ORAL320MG0VALSARTANVALSARTAN

FDA Submissions

UNKNOWN; ORIG1AP2021-10-27

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

SCIEGEN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204038
            [companyName] => SCIEGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-27
        )

)

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