PRINSTON INC FDA Approval ANDA 204413

ANDA 204413

PRINSTON INC

FDA Drug Application

Application #204413

Application Sponsors

ANDA 204413PRINSTON INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 2MG BASE0ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORALEQ 4MG BASE0ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORALEQ 6MG BASE0ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORALEQ 8MG BASE0ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
005TABLET, EXTENDED RELEASE;ORALEQ 12MG BASE0ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-05-11

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204413
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 6MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 8MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 12MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-11
        )

)

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