ANDA 216751

PRASCO

FDA Drug Application

Application #216751

Application Sponsors

ANDA 216751

PRASCO

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	7.5MG	0	MIRTAZAPINE	MIRTAZAPINE
002	TABLET;ORAL	15MG	0	MIRTAZAPINE	MIRTAZAPINE
003	TABLET;ORAL	30MG	0	MIRTAZAPINE	MIRTAZAPINE
004	TABLET;ORAL	45MG	0	MIRTAZAPINE	MIRTAZAPINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

PRASCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216751
            [companyName] => PRASCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"45MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/18\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-18
        )

)