ACME LABS FDA Approval ANDA 214730

ANDA 214730

ACME LABS

FDA Drug Application

Application #214730

Application Sponsors

ANDA 214730ACME LABS

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL0.4MG0TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-05-04STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

ACME LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214730
            [companyName] => ACME LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAMSULOSIN HYDROCHLORIDE","activeIngredients":"TAMSULOSIN HYDROCHLORIDE","strength":"0.4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/04\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-04
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.