AM REGENT FDA Approval ANDA 207496

ANDA 207496

AM REGENT

FDA Drug Application

Application #207496

Application Sponsors

ANDA 207496AM REGENT

Marketing Status

Prescription001

Application Products

001SOLUTION;IM-IV1GM/10ML (100MG/ML)0METHOCARBAMOLMETHOCARBAMOL

FDA Submissions

UNKNOWN; ORIG1AP2017-06-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207496
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"1GM\/10ML (100MG\/ML)","dosageForm":"SOLUTION;IM-IV","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-06-22
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.