HETERO LABS LTD V FDA Approval ANDA 209403

ANDA 209403

HETERO LABS LTD V

FDA Drug Application

Application #209403

Application Sponsors

ANDA 209403HETERO LABS LTD V

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 30MG BASE0CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDE
002TABLET;ORALEQ 60MG BASE0CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDE
003TABLET;ORALEQ 90MG BASE0CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-07STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

HETERO LABS LTD V
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209403
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"CINACALCET HYDROCHLORIDE","activeIngredients":"CINACALCET HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CINACALCET HYDROCHLORIDE","activeIngredients":"CINACALCET HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CINACALCET HYDROCHLORIDE","activeIngredients":"CINACALCET HYDROCHLORIDE","strength":"EQ 90MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-07
        )

)

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