ANDA 213570

SANDOZ INC

FDA Drug Application

Application #213570

Documents

• Letter: 2022-09-27

Application Sponsors

ANDA 213570

SANDOZ INC

Marketing Status

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

Application Products

001	TABLET; ORAL	0.25MG	0	REXULTI	BREXPIPRAZOLE
002	TABLET; ORAL	0.50MG	0	REXULTI	BREXPIPRAZOLE
003	TABLET; ORAL	1MG	0	REXULTI	BREXPIPRAZOLE
004	TABLET; ORAL	2MG	0	REXULTI	BREXPIPRAZOLE
005	TABLET; ORAL	3MG	0	REXULTI	BREXPIPRAZOLE
006	TABLET; ORAL	4MG	0	REXULTI	BREXPIPRAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-26

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

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213570
            [companyName] => SANDOZ 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":"09\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/213570Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-26
        )

)