ANDA 208915

CIPLA

FDA Drug Application

Application #208915

Application Sponsors

ANDA 208915

CIPLA

Marketing Status

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

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-03-08	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-04-02	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-12-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208915
            [companyName] => CIPLA
            [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":"03\/08\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/02\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-02
        )

)