ANDA 205781

PERRIGO UK FINCO

FDA Drug Application

Application #205781

Documents

• Letter: 2017-07-14
• Label: 2017-07-18
• REMS: 2017-10-12

Application Sponsors

ANDA 205781

PERRIGO UK FINCO

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	GEL;TRANSDERMAL	1.62% (20.25MG/1.25GM PACKET)	0	TESTOSTERONE	TESTOSTERONE
002	GEL;TRANSDERMAL	1.62% (40.5MG/2.5GM PACKET)	0	TESTOSTERONE	TESTOSTERONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-07-12	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-06-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15

TE Codes

001	Prescription	AB2
002	Prescription	AB2

CDER Filings

PERRIGO UK FINCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205781
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"1.62% (20.25MG\/1.25GM PACKET)","dosageForm":"GEL;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"1.62% (40.5MG\/2.5GM PACKET)","dosageForm":"GEL;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/12\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205781Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/12\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205781Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205781Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/27\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-27
        )

)