HETERO LABS LTD III FDA Approval ANDA 212278

ANDA 212278

HETERO LABS LTD III

FDA Drug Application

Application #212278

Application Sponsors

ANDA 212278HETERO LABS LTD III

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; ORIG1AP2022-02-02STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212278
            [companyName] => HETERO LABS LTD III
            [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":"02\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-02
        )

)

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