DR REDDYS FDA Approval ANDA 201618

ANDA 201618

DR REDDYS

FDA Drug Application

Application #201618

Application Sponsors

ANDA 201618DR REDDYS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

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

FDA Submissions

N/A; Not ApplicableORIG1AP2021-10-05

Submissions Property Types

ORIG1Null19

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

DR REDDYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201618
            [companyName] => DR REDDYS
            [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\/05\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-05
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.