ANDA 216495

ZYDUS

FDA Drug Application

Application #216495

Application Sponsors

ANDA 216495

ZYDUS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE
002	TABLET;ORAL	EQ 10MG BASE	0	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-08

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

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
        )

)