ANDA 208541

DR REDDYS LABS INC

FDA Drug Application

Application #208541

Documents

• Letter: 2020-12-01

Application Sponsors

ANDA 208541

DR REDDYS LABS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	60MG	0	TICAGRELOR	TICAGRELOR
002	TABLET;ORAL	90MG	0	TICAGRELOR	TICAGRELOR

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-10-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208541
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TICAGRELOR","activeIngredients":"TICAGRELOR","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/29\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-29
        )

)