ANDA 201515

TORRENT PHARMS LTD

FDA Drug Application

Application #201515

Documents

• Letter: 2012-08-07

Application Sponsors

ANDA 201515

TORRENT PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 10MG BASE

0

MONTELUKAST SODIUM

MONTELUKAST SODIUM

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-08-03
LABELING; Labeling	SUPPL	2	AP	2013-01-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-03-01	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-04-07	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-01-04	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-10-05	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-10-05	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-10-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	13	Null	15
SUPPL	16	Null	7
SUPPL	17	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TORRENT PHARMS LTD

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(
    [0] => Array
        (
            [ApplNo] => 201515
            [companyName] => TORRENT PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/03\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201515Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/05\/2020","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/05\/2020","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/04\/2016","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/07\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/01\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/28\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/16\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-05
        )

)