ANDA 213152

AIZANT DRUG RESEARCH SOLUTIONS PVT LTD

FDA Drug Application

Application #213152

Application Sponsors

ANDA 213152

AIZANT DRUG RESEARCH SOLUTIONS PVT LTD

Marketing Status

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

Application Products

002	CAPSULE;ORAL	100MG	0	PALBOCICLIB	PALBOCICLIB
003	CAPSULE;ORAL	125MG	0	PALBOCICLIB	PALBOCICLIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-03-04

STANDARD

Submissions Property Types

ORIG

1

Null

31

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
        )

)