NDA 210238

AKARX INC

FDA Drug Application

Application #210238

Documents

• Label: 2018-05-21
• Letter: 2018-05-24
• Review: 2018-06-28
• Label: 2019-03-22
• Letter: 2019-06-20
• Label: 2019-06-28
• Label: 2020-08-21
• Letter: 2020-08-24
• Label: 2021-10-15
• Letter: 2021-10-19

Application Sponsors

NDA 210238

AKARX INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 20MG BASE

1

DOPTELET

AVATROMBOPAG MALEATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-05-21	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2019-03-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-08-20	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-10-14	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	7

CDER Filings

AKARX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210238
            [companyName] => AKARX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOPTELET","activeIngredients":"AVATROMBOPAG MALEATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/20\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210238s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210238s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210238s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210238s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210238s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210238Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210238Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/20\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210238s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210238Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"03\/21\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210238s002lbl.pdf\"}]","notes":">"},{"actionDate":"06\/26\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210238s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210238Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-08-20
        )

)