MISEMER FDA Approval ANDA 210579

ANDA 210579

MISEMER

FDA Drug Application

Application #210579

Application Sponsors

ANDA 210579MISEMER

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL5MG;2.5MG0CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDECHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-29STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

MISEMER
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210579
            [companyName] => MISEMER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE","activeIngredients":"CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE","strength":"5MG;2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-29
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.