ANDA 090881

SUN PHARM INDS

FDA Drug Application

Application #090881

Application Sponsors

ANDA 090881

SUN PHARM INDS

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

	ORIG	1	AP	2012-02-28
LABELING; Labeling	SUPPL	3	AP	2015-10-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-10-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-10-19	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-06-17	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	8	Null	15

TE Codes

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

CDER Filings

SUN PHARM INDS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90881
            [companyName] => SUN PHARM INDS
            [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":"OLANZAPINE","submission":"OLANZAPINE","actionType":"5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"10MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"15MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"20MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)