ANDA 211948

MYLAN PHARMS INC

FDA Drug Application

Application #211948

Application Sponsors

ANDA 211948

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

82.5MG

0

PREGABALIN

PREGABALIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-09-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211948
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/11\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-11
        )

)