AIZANT DRUG RESEARCH SOLUTIONS PVT LTD FDA Approval ANDA 213152

ANDA 213152

AIZANT DRUG RESEARCH SOLUTIONS PVT LTD

FDA Drug Application

Application #213152

Application Sponsors

ANDA 213152AIZANT DRUG RESEARCH SOLUTIONS PVT LTD

Marketing Status

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

Application Products

002CAPSULE;ORAL100MG0PALBOCICLIBPALBOCICLIB
003CAPSULE;ORAL125MG0PALBOCICLIBPALBOCICLIB

FDA Submissions

UNKNOWN; ORIG1TA2022-03-04STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

AIZANT DRUG RESEARCH SOLUTIONS PVT LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213152
            [companyName] => AIZANT DRUG RESEARCH SOLUTIONS PVT 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":"03\/04\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-04
        )

)

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