ANDA 213313

APOTEX INC

FDA Drug Application

Application #213313

Application Sponsors

ANDA 213313

APOTEX INC

Marketing Status

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

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-07-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213313
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/09\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-09
        )

)