PRINSTON INC FDA Approval ANDA 208880

ANDA 208880

PRINSTON INC

FDA Drug Application

Application #208880

Application Sponsors

ANDA 208880PRINSTON INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG0METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL750MG0METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-09-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB1
002PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208880
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/10\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-10
        )

)

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