ANDA 210362

CIPLA

FDA Drug Application

Application #210362

Application Sponsors

ANDA 210362

CIPLA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	100MG/ML	0	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE
002	INJECTABLE;INJECTION	200MG/ML	0	TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-06-19	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001	Prescription	AO
002	Prescription	AO

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210362
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE CYPIONATE","activeIngredients":"TESTOSTERONE CYPIONATE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TESTOSTERONE CYPIONATE","activeIngredients":"TESTOSTERONE CYPIONATE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/19\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-19
        )

)