ANDA 091265

APOTEX INC

FDA Drug Application

Application #091265

Application Sponsors

ANDA 091265

APOTEX 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

	ORIG	1	AP	2011-10-24
LABELING; Labeling	SUPPL	3	AP	2022-07-08	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-07-08	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-07-08	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-07-08	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-07-08	STANDARD
LABELING; Labeling	SUPPL	15	AP	2022-07-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	6	Null	15
SUPPL	10	Null	15
SUPPL	12	Null	31
SUPPL	13	Null	15
SUPPL	15	Null	15

TE Codes

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

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91265
            [companyName] => APOTEX 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":"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
        )

)