AMNEAL PHARMS FDA Approval ANDA 204364

ANDA 204364

AMNEAL PHARMS

FDA Drug Application

Application #204364

Application Sponsors

ANDA 204364AMNEAL PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL30MG0CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDE
002TABLET;ORAL60MG0CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDE
003TABLET;ORAL90MG0CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-12-02

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

AMNEAL PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204364
            [companyName] => AMNEAL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CINACALCET HYDROCHLORIDE","activeIngredients":"CINACALCET HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CINACALCET HYDROCHLORIDE","activeIngredients":"CINACALCET HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CINACALCET HYDROCHLORIDE","activeIngredients":"CINACALCET HYDROCHLORIDE","strength":"90MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-02
        )

)

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