DR REDDYS FDA Approval ANDA 201942

ANDA 201942

DR REDDYS

FDA Drug Application

Application #201942

Application Sponsors

ANDA 201942DR REDDYS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 0.5MG BASE0RASAGILINE MESYLATERASAGILINE MESYLATE
002TABLET;ORALEQ 1MG BASE0RASAGILINE MESYLATERASAGILINE MESYLATE

FDA Submissions

N/A; Not ApplicableORIG1AP2021-11-18

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

DR REDDYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201942
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RASAGILINE MESYLATE","activeIngredients":"RASAGILINE MESYLATE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RASAGILINE MESYLATE","activeIngredients":"RASAGILINE MESYLATE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-18
        )

)

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