ANDA 204268

PERRIGO ISRAEL

FDA Drug Application

Application #204268

Documents

• Letter: 2015-08-06
• Other: 2015-08-14

Application Sponsors

ANDA 204268

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

GEL, METERED;TRANSDERMAL

1.62% (20.25MG/1.25GM ACTUATION)

0

TESTOSTERONE

TESTOSTERONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-08-04
LABELING; Labeling	SUPPL	4	AP	2019-06-27	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204268
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"1.62% (20.25MG\/1.25GM ACTUATION)","dosageForm":"GEL, METERED;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204268Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/27\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-27
        )

)