DR REDDYS LABS LTD FDA Approval ANDA 213091

ANDA 213091

DR REDDYS LABS LTD

FDA Drug Application

Application #213091

Documents

Letter2021-09-02

Application Sponsors

ANDA 213091DR REDDYS LABS LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003

Application Products

001CAPSULE;ORAL75MG0PALBOCICLIBPALBOCICLIB
002CAPSULE;ORAL100MG0PALBOCICLIBPALBOCICLIB
003CAPSULE;ORAL125MG0PALBOCICLIBPALBOCICLIB

FDA Submissions

UNKNOWN; ORIG1TA2021-08-18STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213091
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALBOCICLIB","activeIngredients":"PALBOCICLIB","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PALBOCICLIB","activeIngredients":"PALBOCICLIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PALBOCICLIB","activeIngredients":"PALBOCICLIB","strength":"125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-18
        )

)

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