ANDA 212798

LEADING PHARMA LLC

FDA Drug Application

Application #212798

Application Sponsors

ANDA 212798

LEADING PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

OXYBUTYNIN CHLORIDE

OXYBUTYNIN CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-04-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

LEADING PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212798
            [companyName] => LEADING PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-06
        )

)