ANDA 201593

TORRENT

FDA Drug Application

Application #201593

Documents

• Letter: 2014-11-04
• Letter: 2015-06-10

Application Sponsors

ANDA 201593

TORRENT

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	TABLET;ORAL	EQ 5MG BASE;12.5MG;160MG	0	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
002	TABLET;ORAL	EQ 5MG BASE;25MG;160MG	0	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
003	TABLET;ORAL	EQ 10MG BASE;12.5MG;160MG	0	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
004	TABLET;ORAL	EQ 10MG BASE;25MG;160MG	0	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
005	TABLET;ORAL	EQ 10MG BASE;25MG;320MG	0	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-06-03

Submissions Property Types

ORIG

1

Null

17

CDER Filings

TORRENT

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(
    [0] => Array
        (
            [ApplNo] => 201593
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 5MG BASE;12.5MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 5MG BASE;25MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 10MG BASE;12.5MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 10MG BASE;25MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 10MG BASE;25MG;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/03\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201593Orig1s000TAltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/201593Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/05\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-02-05
        )

)