ANDA 091434

TORRENT PHARMS LTD

FDA Drug Application

Application #091434

Application Sponsors

ANDA 091434

TORRENT 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

	ORIG	1	AP	2012-04-23
LABELING; Labeling	SUPPL	8	AP	2014-12-08	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-07-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-07-13	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-07-13	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-07-13	STANDARD
LABELING; Labeling	SUPPL	15	AP	2022-07-13	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-07-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	15

TE Codes

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

CDER Filings

TORRENT PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91434
            [companyName] => TORRENT PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OLANZAPINE","submission":"OLANZAPINE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)