TEVA PHARMS USA FDA Approval ANDA 211149

ANDA 211149

TEVA PHARMS USA

FDA Drug Application

Application #211149

Application Sponsors

ANDA 211149TEVA PHARMS USA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR39MG/0.25ML (39MG/0.25ML)0PALIPERIDONE PALMITATEPALIPERIDONE PALMITATE
002SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR78MG/0.5ML (78MG/0.5ML)0PALIPERIDONE PALMITATEPALIPERIDONE PALMITATE
003SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR117MG/0.75ML (117MG/0.75ML)0PALIPERIDONE PALMITATEPALIPERIDONE PALMITATE
004SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR156MG/ML (156MG/ML)0PALIPERIDONE PALMITATEPALIPERIDONE PALMITATE
005SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR234MG/1.5ML (156MG/ML)0PALIPERIDONE PALMITATEPALIPERIDONE PALMITATE

FDA Submissions

UNKNOWN; ORIG1AP2021-07-06STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP
005PrescriptionAP

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211149
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALIPERIDONE PALMITATE","activeIngredients":"PALIPERIDONE PALMITATE","strength":"39MG\/0.25ML (39MG\/0.25ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE PALMITATE","activeIngredients":"PALIPERIDONE PALMITATE","strength":"78MG\/0.5ML (78MG\/0.5ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE PALMITATE","activeIngredients":"PALIPERIDONE PALMITATE","strength":"117MG\/0.75ML (117MG\/0.75ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE PALMITATE","activeIngredients":"PALIPERIDONE PALMITATE","strength":"156MG\/ML (156MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE PALMITATE","activeIngredients":"PALIPERIDONE PALMITATE","strength":"234MG\/1.5ML (156MG\/ML)","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-06
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.