ANDA 213692

TEVA PHARMS USA INC

FDA Drug Application

Application #213692

Documents

• Letter: 2022-09-07

Application Sponsors

ANDA 213692

TEVA PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	0.25MG	0	BREXPIPRAZOLE	BREXPIPRAZOLE
002	TABLET;ORAL	0.5MG	0	BREXPIPRAZOLE	BREXPIPRAZOLE
003	TABLET;ORAL	1MG	0	BREXPIPRAZOLE	BREXPIPRAZOLE
004	TABLET;ORAL	2MG	0	BREXPIPRAZOLE	BREXPIPRAZOLE
005	TABLET;ORAL	3MG	0	BREXPIPRAZOLE	BREXPIPRAZOLE
006	TABLET;ORAL	4MG	0	BREXPIPRAZOLE	BREXPIPRAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213692
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-11
        )

)