JB CHEMS PHARMS FDA Approval ANDA 216044

ANDA 216044

JB CHEMS PHARMS

FDA Drug Application

Application #216044

Application Sponsors

ANDA 216044JB CHEMS PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 37.5MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORALEQ 75MG BASE00VENLAFAXINE HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORALEQ 150MG BASE00VENLAFAXINE HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORALEQ 225MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-11-28STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

JB CHEMS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216044
            [companyName] => JB CHEMS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 37.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 225MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-28
        )

)

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