ANDA 091244

HIKMA FARMACEUTICA

FDA Drug Application

Application #091244

Documents

• Review: 2013-01-22
• Other: 2018-05-01

Application Sponsors

ANDA 091244

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

200MG/ML

0

TESTOSTERONE CYPIONATE

TESTOSTERONE CYPIONATE

FDA Submissions

	ORIG	1	AP	2012-05-01
S; Supplement	SUPPL	2	AP	2016-07-26
LABELING; Labeling	SUPPL	4	AP	2014-06-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-05-11	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-07-22	STANDARD
LABELING; Labeling	SUPPL	7	AP	2017-03-27	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	0
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AO

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91244
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE CYPIONATE","activeIngredients":"TESTOSTERONE CYPIONATE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TESTOSTERONE CYPIONATE","submission":"TESTOSTERONE CYPIONATE","actionType":"200MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)