ANDA 209335

ABHAI LLC

FDA Drug Application

Application #209335

Application Sponsors

ANDA 209335

ABHAI LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

OXYBUTYNIN CHLORIDE

OXYBUTYNIN CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ABHAI LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209335
            [companyName] => ABHAI LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-22
        )

)