DR REDDYS LABS LTD FDA Approval NDA 212157

NDA 212157

DR REDDYS LABS LTD

FDA Drug Application

Application #212157

Documents

Label2020-05-05
Medication Guide2020-05-05
Letter2020-05-06
Review2020-07-28
Letter2021-04-30
Label2021-05-03

Application Sponsors

NDA 212157DR REDDYS LABS LTD

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL120MG/4.8ML(25MG/ML)2ELYXYBCELECOXIB

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2020-05-05STANDARD
LABELING; LabelingSUPPL2AP2021-04-28STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15

CDER Filings

DR REDDYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212157
            [companyName] => DR REDDYS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/212157s000lbl.pdf#page=24"]
            [products] => [{"drugName":"ELYXYB","activeIngredients":"CELECOXIB","strength":"25MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/05\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212157s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/05\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212157s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212157Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/212157Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-05
        )

)

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