TORRENT FDA Approval ANDA 206515

ANDA 206515

TORRENT

FDA Drug Application

Application #206515

Documents

Letter2017-05-09

Application Sponsors

ANDA 206515TORRENT

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL12.5MG;20MG0OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
002TABLET;ORAL12.5MG;40MG0OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
003TABLET;ORAL25MG;40MG0OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

FDA Submissions

UNKNOWN; ORIG1AP2017-05-03STANDARD
LABELING; LabelingSUPPL13AP2023-01-17STANDARD

Submissions Property Types

ORIG1Null15
SUPPL13Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206515
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"12.5MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"12.5MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"25MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/03\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206515Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-03
        )

)

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