ZYDUS FDA Approval ANDA 216495

ANDA 216495

ZYDUS

FDA Drug Application

Application #216495

Application Sponsors

ANDA 216495ZYDUS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 5MG BASE0PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATE
002TABLET;ORALEQ 10MG BASE0PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-08STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ZYDUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216495
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCHLORPERAZINE MALEATE","activeIngredients":"PROCHLORPERAZINE MALEATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROCHLORPERAZINE MALEATE","activeIngredients":"PROCHLORPERAZINE MALEATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-08
        )

)

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