ANDA 210125

TULEX PHARMS INC

FDA Drug Application

Application #210125

Application Sponsors

ANDA 210125

TULEX PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

OXYBUTYNIN CHLORIDE

OXYBUTYNIN CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-09-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TULEX PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210125
            [companyName] => TULEX PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/06\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-06
        )

)