ANDA 206892

PHARMTAK INC

FDA Drug Application

Application #206892

Application Sponsors

ANDA 206892

PHARMTAK INC

Marketing Status

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

2020-12-31

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

PHARMTAK INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206892
            [companyName] => PHARMTAK INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"15MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"20MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/31\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-31
        )

)