ANDA 204364

AMNEAL PHARMS

FDA Drug Application

Application #204364

Application Sponsors

ANDA 204364

AMNEAL PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	30MG	0	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE
002	TABLET;ORAL	60MG	0	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE
003	TABLET;ORAL	90MG	0	CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-12-02

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

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
        )

)