ANDA 209480

ZYDUS PHARMS

FDA Drug Application

Application #209480

Documents

• Letter: 2017-12-12

Application Sponsors

ANDA 209480

ZYDUS PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	25MG	0	CLOZAPINE	CLOZAPINE
002	TABLET;ORAL	50MG	0	CLOZAPINE	CLOZAPINE
003	TABLET;ORAL	100MG	0	CLOZAPINE	CLOZAPINE
004	TABLET;ORAL	200MG	0	CLOZAPINE	CLOZAPINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209480
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209480Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-06
        )

)