ANDA 209399

JIANGSU HANSOH PHARM

FDA Drug Application

Application #209399

Application Sponsors

ANDA 209399

JIANGSU HANSOH PHARM

Marketing Status

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

Application Products

001	TABLET;ORAL	2.5MG	0	OLANZAPINE	OLANZAPINE
002	TABLET;ORAL	5MG	0	OLANZAPINE	OLANZAPINE
003	TABLET;ORAL	10MG	0	OLANZAPINE	OLANZAPINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-09-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

JIANGSU HANSOH PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209399
            [companyName] => JIANGSU HANSOH PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-24
        )

)