ANDA 213550

BEXIMCO PHARMS USA

FDA Drug Application

Application #213550

Application Sponsors

ANDA 213550

BEXIMCO PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

OXYBUTYNIN CHLORIDE

OXYBUTYNIN CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-07-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

BEXIMCO PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213550
            [companyName] => BEXIMCO PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/14\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-14
        )

)