DR REDDYS LABS LTD FDA Approval ANDA 206994

ANDA 206994

DR REDDYS LABS LTD

FDA Drug Application

Application #206994

Application Sponsors

ANDA 206994DR REDDYS LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL8MCG0LUBIPROSTONELUBIPROSTONE
002CAPSULE;ORAL24MCG0LUBIPROSTONELUBIPROSTONE

FDA Submissions

UNKNOWN; ORIG1AP2022-02-08STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206994
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUBIPROSTONE","activeIngredients":"LUBIPROSTONE","strength":"8MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LUBIPROSTONE","activeIngredients":"LUBIPROSTONE","strength":"24MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-08
        )

)

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