DR REDDYS LABS LTD FDA Approval NDA 206927

NDA 206927

DR REDDYS LABS LTD

FDA Drug Application

Application #206927

Documents

Label2019-10-07
Letter2019-10-07
Review2020-02-21
Letter2022-03-01
Label2022-03-02

Application Sponsors

NDA 206927DR REDDYS LABS LTD

Marketing Status

Prescription001

Application Products

001POWDER;INTRAVENOUS3.5MG/VIAL0BORTEZOMIBBORTEZOMIB

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2019-10-04STANDARD
LABELING; LabelingSUPPL2AP2022-02-28STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null7

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206927
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"3.5MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/04\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206927s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206927s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206927Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/206927Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-10-04
        )

)

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