NDA 204824

ANTARES PHARMA INC

FDA Drug Application

Application #204824

Documents

• Letter: 2014-11-12
• Label: 2013-10-17
• Label: 2016-05-27
• Letter: 2013-10-16
• Label: 2014-11-10
• Review: 2014-02-03
• Label: 2017-07-27
• Label: 2018-03-16
• Letter: 2018-03-20
• Label: 2019-06-20
• Letter: 2019-06-20
• Review: 2019-07-09
• Label: 2019-07-09
• Letter: 2019-07-09
• Letter: 2019-12-27
• Label: 2020-01-02

Application Sponsors

NDA 204824

ANTARES PHARMA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Discontinued: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008
• Discontinued: 009
• Discontinued: 010
• Discontinued: 011
• Discontinued: 012
• Discontinued: 013
• Discontinued: 014

Application Products

001	SOLUTION;SUBCUTANEOUS	10MG/0.4ML (10MG/0.4ML)	1	OTREXUP	METHOTREXATE
002	SOLUTION;SUBCUTANEOUS	15MG/0.4ML (15MG/0.4ML)	1	OTREXUP	METHOTREXATE
003	SOLUTION;SUBCUTANEOUS	20MG/0.4ML (20MG/0.4ML)	1	OTREXUP	METHOTREXATE
004	SOLUTION;SUBCUTANEOUS	25MG/0.4ML (25MG/0.4ML)	1	OTREXUP	METHOTREXATE
005	SOLUTION;SUBCUTANEOUS	7.5MG/0.4ML (7.5MG/0.4ML)	1	OTREXUP	METHOTREXATE
006	SOLUTION;SUBCUTANEOUS	12.5MG/0.4ML (12.5MG/0.4ML)	1	OTREXUP	METHOTREXATE
007	SOLUTION;SUBCUTANEOUS	17.5MG/0.4ML (17.5MG/0.4ML)	1	OTREXUP	METHOTREXATE
008	SOLUTION;SUBCUTANEOUS	22.5MG/0.4ML (22.5MG/0.4ML)	1	OTREXUP	METHOTREXATE
009	SOLUTION;SUBCUTANEOUS	10MG/0.4ML (10MG/0.4ML)	1	OTREXUP PFS	METHOTREXATE
010	SOLUTION;SUBCUTANEOUS	15MG/0.6ML (15MG/0.6ML)	1	OTREXUP PFS	METHOTREXATE
011	SOLUTION;SUBCUTANEOUS	17.5MG/0.7ML (17.5MG/0.7ML)	1	OTREXUP PFS	METHOTREXATE
012	SOLUTION;SUBCUTANEOUS	20MG/0.8ML (20MG/0.8ML)	1	OTREXUP PFS	METHOTREXATE
013	SOLUTION;SUBCUTANEOUS	22.5MG/0.9ML (22.5MG/0.9ML)	1	OTREXUP PFS	METHOTREXATE
014	SOLUTION;SUBCUTANEOUS	25MG/ML (25MG/ML)	1	OTREXUP PFS	METHOTREXATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2013-10-11	STANDARD
EFFICACY; Efficacy	ORIG	2	AP	2013-10-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2016-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2017-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2017-05-31	STANDARD
LABELING; Labeling	SUPPL	8	AP	2018-03-15	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-06-19	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-12-26	STANDARD

Submissions Property Types

ORIG	1	Null	6
ORIG	2	Null	6
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	8	Null	15
SUPPL	9	Null	6
SUPPL	10	Null	7

CDER Filings

ANTARES PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204824
            [companyName] => ANTARES PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OTREXUP","activeIngredients":"METHOTREXATE","strength":"10MG\/0.4ML (10MG\/0.4ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OTREXUP","activeIngredients":"METHOTREXATE","strength":"15MG\/0.4ML (15MG\/0.4ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OTREXUP","activeIngredients":"METHOTREXATE","strength":"20MG\/0.4ML (20MG\/0.4ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OTREXUP","activeIngredients":"METHOTREXATE","strength":"25MG\/0.4ML (25MG\/0.4ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OTREXUP","activeIngredients":"METHOTREXATE","strength":"7.5MG\/0.4ML (7.5MG\/0.4ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OTREXUP","activeIngredients":"METHOTREXATE","strength":"12.5MG\/0.4ML (12.5MG\/0.4ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OTREXUP","activeIngredients":"METHOTREXATE","strength":"17.5MG\/0.4ML (17.5MG\/0.4ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OTREXUP","activeIngredients":"METHOTREXATE","strength":"22.5MG\/0.4ML (22.5MG\/0.4ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OTREXUP PFS","activeIngredients":"METHOTREXATE","strength":"10MG\/0.4ML (10MG\/0.4ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OTREXUP PFS","activeIngredients":"METHOTREXATE","strength":"15MG\/0.6ML (15MG\/0.6ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OTREXUP PFS","activeIngredients":"METHOTREXATE","strength":"17.5MG\/0.7ML (17.5MG\/0.7ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OTREXUP PFS","activeIngredients":"METHOTREXATE","strength":"20MG\/0.8ML (20MG\/0.8ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OTREXUP PFS","activeIngredients":"METHOTREXATE","strength":"22.5MG\/0.9ML (22.5MG\/0.9ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OTREXUP PFS","activeIngredients":"METHOTREXATE","strength":"25MG\/ML (25MG\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/26\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204824s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/26\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204824s010lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204824s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204824s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2017","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204824s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2016","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204824s004lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"11\/07\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204824s003lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"10\/11\/2013","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204824Orig2s000Lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204824Orig1s000Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/11\/2013","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Efficacy","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204824Orig2s000Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204824Orig1s000,204824Orig2s000_replace_ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204824Orig2s000TOC.cfm\"}]","notes":">"},{"actionDate":"10\/11\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204824Orig1s000Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204824Orig1s000,204824Orig2s000_replace_ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204824Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/26\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204824s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204824Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"06\/19\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204824s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204824Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"03\/15\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204824s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/2018\\\/204824Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"05\/31\/2017","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204824s006lbl.pdf\"}]","notes":">"},{"actionDate":"01\/11\/2017","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/24\/2016","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204824s004lbl.pdf\"}]","notes":">"},{"actionDate":"11\/07\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204824s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204824Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"10\/08\/2014","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/07\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-26
        )

)