ANDA 090984

TORRENT PHARMS LTD

FDA Drug Application

Application #090984

Documents

• Letter: 2012-08-07

Application Sponsors

ANDA 090984

TORRENT PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, CHEWABLE;ORAL	EQ 4MG BASE	0	MONTELUKAST SODIUM	MONTELUKAST SODIUM
002	TABLET, CHEWABLE;ORAL	EQ 5MG BASE	0	MONTELUKAST SODIUM	MONTELUKAST SODIUM

FDA Submissions

	ORIG	1	AP	2012-08-03
LABELING; Labeling	SUPPL	2	AP	2013-01-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2013-08-14	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-04-07	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-01-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-01-04	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-10-05	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-10-05	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-10-15	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	8
SUPPL	3	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	11	Null	15
SUPPL	13	Null	7
SUPPL	16	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

TORRENT PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90984
            [companyName] => TORRENT PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 4MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MONTELUKAST SODIUM","submission":"MONTELUKAST SODIUM","actionType":"EQ 4MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MONTELUKAST SODIUM","submission":"MONTELUKAST SODIUM","actionType":"EQ 5MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)