ANDA 216649

APOTEX

FDA Drug Application

Application #216649

Application Sponsors

ANDA 216649

APOTEX

Marketing Status

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

Application Products

001	TABLET;ORAL	1MG	0	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE
002	TABLET;ORAL	2.5MG	0	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE
003	TABLET;ORAL	5MG	0	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE
004	TABLET;ORAL	10MG	0	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-07-15

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216649
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-15
        )

)