ANDA 211889

SUN PHARM INDS LTD

FDA Drug Application

Application #211889

Application Sponsors

ANDA 211889

SUN PHARM INDS LTD

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	82.5MG	0	PREGABALIN	PREGABALIN
002	TABLET, EXTENDED RELEASE;ORAL	165MG	0	PREGABALIN	PREGABALIN
003	TABLET, EXTENDED RELEASE;ORAL	330MG	0	PREGABALIN	PREGABALIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-03-25

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211889
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"82.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"165MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"330MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-13
        )

)