LAURUS LABS LTD FDA Approval ANDA 212579

ANDA 212579

LAURUS LABS LTD

FDA Drug Application

Application #212579

Application Sponsors

ANDA 212579LAURUS LABS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2021-04-30STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

LAURUS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212579
            [companyName] => LAURUS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"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":"ATAZANAVIR SULFATE","submission":"ATAZANAVIR SULFATE","actionType":"EQ 150MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATAZANAVIR SULFATE","submission":"ATAZANAVIR SULFATE","actionType":"EQ 200MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATAZANAVIR SULFATE","submission":"ATAZANAVIR SULFATE","actionType":"EQ 300MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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