TORRENT FDA Approval ANDA 202377

ANDA 202377

TORRENT

FDA Drug Application

Application #202377

Application Sponsors

ANDA 202377TORRENT

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001TABLET;ORALEQ 5MG BASE;160MG0AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTAN
002TABLET;ORALEQ 5MG BASE;320MG0AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTAN
003TABLET;ORALEQ 10MG BASE;160MG0AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTAN
004TABLET;ORALEQ 10MG BASE;320MG0AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTAN

FDA Submissions

UNKNOWN; ORIG1AP2015-03-30

Submissions Property Types

ORIG1Null7

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202377
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BESYLATE AND VALSARTAN","activeIngredients":"AMLODIPINE BESYLATE; VALSARTAN","strength":"EQ 5MG BASE;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND VALSARTAN","activeIngredients":"AMLODIPINE BESYLATE; VALSARTAN","strength":"EQ 5MG BASE;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND VALSARTAN","activeIngredients":"AMLODIPINE BESYLATE; VALSARTAN","strength":"EQ 10MG BASE;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND VALSARTAN","activeIngredients":"AMLODIPINE BESYLATE; VALSARTAN","strength":"EQ 10MG BASE;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-03-30
        )

)

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