ALKEM LABS LTD FDA Approval ANDA 209042

ANDA 209042

ALKEM LABS LTD

FDA Drug Application

Application #209042

Application Sponsors

ANDA 209042ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORALEQ 5MG BASE;20MG0AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
002TABLET;ORALEQ 5MG BASE;40MG0AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
003TABLET;ORALEQ 10MG BASE;20MG0AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
004TABLET;ORALEQ 10MG BASE;40MG0AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

FDA Submissions

UNKNOWN; ORIG1AP2017-08-14STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209042
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE AND OLMESARTAN MEDOXOMIL","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 5MG BASE;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE AND OLMESARTAN MEDOXOMIL","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 5MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE AND OLMESARTAN MEDOXOMIL","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 10MG BASE;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE AND OLMESARTAN MEDOXOMIL","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 10MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/14\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-14
        )

)

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