ANDA 204320

AJANTA PHARMA LTD

FDA Drug Application

Application #204320

Application Sponsors

ANDA 204320

AJANTA PHARMA LTD

Marketing Status

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

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	0	OLANZAPINE	OLANZAPINE
002	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	0	OLANZAPINE	OLANZAPINE
003	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	0	OLANZAPINE	OLANZAPINE
004	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	0	OLANZAPINE	OLANZAPINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-05-30

Submissions Property Types

ORIG

1

Null

7

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204320
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"15MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"20MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/30\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-30
        )

)