ANDA 213107

SUN PHARM INDS LTD

FDA Drug Application

Application #213107

Application Sponsors

ANDA 213107

SUN PHARM INDS LTD

Marketing Status

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

Application Products

001	CAPSULE; ORAL	75MG	0	PALBOCICLIB	PALBOCICLIB
002	CAPSULE; ORAL	100MG	0	PALBOCICLIB	PALBOCICLIB
003	CAPSULE; ORAL	125MG	0	PALBOCICLIB	PALBOCICLIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-04-30

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213107
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALBOCICLIB","activeIngredients":"PALBOCICLIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/30\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-30
        )

)