BEXIMCO PHARMS USA FDA Approval ANDA 213550

ANDA 213550

BEXIMCO PHARMS USA

FDA Drug Application

Application #213550

Application Sponsors

ANDA 213550BEXIMCO PHARMS USA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL5MG0OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-14STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

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
        )

)

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