NDA 211801

ARDELYX INC

FDA Drug Application

Application #211801

Documents

• Label: 2019-09-12
• Medication Guide: 2019-09-12
• Letter: 2019-09-13
• Review: 2019-10-15
• Letter: 2021-03-09
• Label: 2021-05-20
• Letter: 2021-05-20
• Review: 2021-09-24
• Medication Guide: 2021-10-04
• Letter: 2022-04-06
• Label: 2022-04-06
• Medication Guide: 2022-04-06

Application Sponsors

NDA 211801

ARDELYX INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 50MG BASE

1

IBSRELA

TENAPANOR HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-09-12	STANDARD
LABELING; Labeling	SUPPL	2	TA	2020-09-09	UNKNOWN
LABELING; Labeling	SUPPL	3	AP	2021-05-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-04-05	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7

CDER Filings

ARDELYX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211801
            [companyName] => ARDELYX INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/211801s000lbl.pdf#page=13"]
            [products] => [{"drugName":"IBSRELA","activeIngredients":"TENAPANOR HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/12\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211801s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211801s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211801Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211801Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-09-12
        )

)