ANDA 091120

HIKMA FARMACEUTICA

FDA Drug Application

Application #091120

Application Sponsors

ANDA 091120

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

200MG/ML

0

TESTOSTERONE ENANTHATE

TESTOSTERONE ENANTHATE

FDA Submissions

	ORIG	1	AP	2012-09-18
LABELING; Labeling	SUPPL	2	AP	2014-11-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-09-08	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-10-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AO

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91120
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE ENANTHATE","activeIngredients":"TESTOSTERONE ENANTHATE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TESTOSTERONE ENANTHATE","submission":"TESTOSTERONE ENANTHATE","actionType":"200MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)