ANDA 213660

ZYDUS PHARMS USA INC

FDA Drug Application

Application #213660

Documents

• Letter: 2021-10-08

Application Sponsors

ANDA 213660

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005
• None (Tentative Approval): 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

TA

2021-09-08

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

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

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213660
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/08\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213660Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-08
        )

)