NDA 209863

ANTARES PHARMA INC

FDA Drug Application

Application #209863

Documents

• Label: 2018-10-03
• Medication Guide: 2018-10-03
• Letter: 2018-10-11
• Review: 2019-03-27
• Letter: 2019-11-20
• Label: 2019-11-20

Application Sponsors

NDA 209863

ANTARES PHARMA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;SUBCUTANEOUS	50MG/0.5ML (50MG/0.5ML)	1	XYOSTED (AUTOINJECTOR)	TESTOSTERONE ENANTHATE
002	SOLUTION;SUBCUTANEOUS	75MG/0.5ML (75MG/0.5ML)	1	XYOSTED (AUTOINJECTOR)	TESTOSTERONE ENANTHATE
003	SOLUTION;SUBCUTANEOUS	100MG/0.5ML (100MG/0.5ML)	1	XYOSTED (AUTOINJECTOR)	TESTOSTERONE ENANTHATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2018-09-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-11-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	33

CDER Filings

ANTARES PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209863
            [companyName] => ANTARES PHARMA INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/209863s000lbl.pdf#page=16"]
            [products] => [{"drugName":"XYOSTED (AUTOINJECTOR)","activeIngredients":"TESTOSTERONE ENANTHATE","strength":"50MG\/0.5ML (50MG\/0.5ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"XYOSTED (AUTOINJECTOR)","activeIngredients":"TESTOSTERONE ENANTHATE","strength":"75MG\/0.5ML (75MG\/0.5ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"XYOSTED (AUTOINJECTOR)","activeIngredients":"TESTOSTERONE ENANTHATE","strength":"100MG\/0.5ML (100MG\/0.5ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/19\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209863s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209863s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/28\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209863s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209863Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/209863Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/19\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209863s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209863Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-11-19
        )

)