ANDA 204255

PERRIGO ISRAEL

FDA Drug Application

Application #204255

Documents

• REMS: 2017-03-03
• Label: 2017-03-08

Application Sponsors

ANDA 204255

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION, METERED;TRANSDERMAL

30MG/1.5ML ACTUATION

0

TESTOSTERONE

TESTOSTERONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-02-28
LABELING; Labeling	SUPPL	2	AP	2019-04-24	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-04-24	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-05-10	STANDARD
REMS; REMS	SUPPL	5	AP	2019-05-31

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AT

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204255
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"30MG\/1.5ML ACTUATION","dosageForm":"SOLUTION, METERED;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/28\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204255Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204255Orig1s000lbl.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/31\/2019","submission":"SUPPL-5","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-31
        )

)