ANDA 202517

TORRENT

FDA Drug Application

Application #202517

Documents

• Letter: 2014-08-29
• Letter: 2014-09-04

Application Sponsors

ANDA 202517

TORRENT

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	EQ 5MG BASE;40MG	0	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN
002	TABLET;ORAL	EQ 10MG BASE;40MG	0	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN
003	TABLET;ORAL	EQ 5MG BASE;80MG	0	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN
004	TABLET;ORAL	EQ 10MG BASE;80MG	0	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-01-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2014-06-20
LABELING; Labeling	SUPPL	3	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-04-04	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-04-04	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	0
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	7	Null	15

TE Codes

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

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202517
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"TELMISARTAN AND AMLODIPINE","activeIngredients":"AMLODIPINE BESYLATE; TELMISARTAN","strength":"EQ 5MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN AND AMLODIPINE","activeIngredients":"AMLODIPINE BESYLATE; TELMISARTAN","strength":"EQ 10MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN AND AMLODIPINE","activeIngredients":"AMLODIPINE BESYLATE; TELMISARTAN","strength":"EQ 5MG BASE;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN AND AMLODIPINE","activeIngredients":"AMLODIPINE BESYLATE; TELMISARTAN","strength":"EQ 10MG BASE;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/08\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202517Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/04\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/04\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/30\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/20\/2014","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202517Orig1s002ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-04-04
        )

)