ANDA 213091

DR REDDYS LABS LTD

FDA Drug Application

Application #213091

Documents

• Letter: 2021-09-02

Application Sponsors

ANDA 213091

DR REDDYS LABS 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

2021-08-18

STANDARD

Submissions Property Types

ORIG

1

Null

31

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
        )

)