ANDA 202862

MACLEODS PHARMS LTD

FDA Drug Application

Application #202862

Application Sponsors

ANDA 202862

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	2.5MG	0	OLANZAPINE	OLANZAPINE
002	TABLET;ORAL	5MG	0	OLANZAPINE	OLANZAPINE
003	TABLET;ORAL	7.5MG	0	OLANZAPINE	OLANZAPINE
004	TABLET;ORAL	10MG	0	OLANZAPINE	OLANZAPINE
005	TABLET;ORAL	15MG	0	OLANZAPINE	OLANZAPINE
006	TABLET;ORAL	20MG	0	OLANZAPINE	OLANZAPINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2015-11-05	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2015-11-05	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-11-19	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-11-19	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-11-19	STANDARD
LABELING; Labeling	SUPPL	25	AP	2021-11-19	STANDARD
LABELING; Labeling	SUPPL	26	AP	2021-11-19	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	3	Null	7
SUPPL	5	Null	7
SUPPL	10	Null	31
SUPPL	11	Null	15
SUPPL	18	Null	15
SUPPL	25	Null	7
SUPPL	26	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202862
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/15\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/05\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/05\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/05\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-11-05
        )

)