YICHANG HUMANWELL FDA Approval ANDA 210014

ANDA 210014

YICHANG HUMANWELL

FDA Drug Application

Application #210014

Application Sponsors

ANDA 210014YICHANG HUMANWELL

Marketing Status

Discontinued001
Discontinued002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 50MG BASE0DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATE
002TABLET, EXTENDED RELEASE;ORALEQ 100MG BASE0DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATE
003TABLET, EXTENDED RELEASE;ORALEQ 25MG BASE0DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATE

FDA Submissions

UNKNOWN; ORIG1AP2018-10-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

YICHANG HUMANWELL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210014
            [companyName] => YICHANG HUMANWELL
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESVENLAFAXINE SUCCINATE","activeIngredients":"DESVENLAFAXINE SUCCINATE","strength":"EQ 50MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESVENLAFAXINE SUCCINATE","activeIngredients":"DESVENLAFAXINE SUCCINATE","strength":"EQ 100MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESVENLAFAXINE SUCCINATE","activeIngredients":"DESVENLAFAXINE SUCCINATE","strength":"EQ 25MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/01\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-01
        )

)

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