AMNEAL FDA Approval ANDA 209717

ANDA 209717

AMNEAL

FDA Drug Application

Application #209717

Application Sponsors

ANDA 209717AMNEAL

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORALEQ 100MG BASE0ATAZANAVIR SULFATEATAZANAVIR SULFATE
002CAPSULE;ORALEQ 150MG BASE0ATAZANAVIR SULFATEATAZANAVIR SULFATE
003CAPSULE;ORALEQ 200MG BASE0ATAZANAVIR SULFATEATAZANAVIR SULFATE
004CAPSULE;ORALEQ 300MG BASE0ATAZANAVIR SULFATEATAZANAVIR SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209717
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATAZANAVIR SULFATE","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATAZANAVIR SULFATE","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATAZANAVIR SULFATE","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATAZANAVIR SULFATE","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 300MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-01
        )

)

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