NDA 022127

SANOFI

FDA Drug Application

Application #022127

Documents

• Letter: 2014-11-28
• Label: 2007-10-22
• Label: 2011-06-16
• Label: 2014-12-17
• Label: 2016-03-14
• Review: 2008-08-29
• Summary Review: 2008-08-29
• Letter: 2007-10-22
• Letter: 2011-06-24
• Letter: 2016-03-11
• Letter: 2016-11-28
• Label: 2016-12-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2020-05-01
• Label: 2020-05-04

Application Sponsors

NDA 022127

SANOFI

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

800MG

1

RENVELA

SEVELAMER CARBONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2007-10-19	STANDARD
LABELING; Labeling	SUPPL	8	AP	2011-06-16	UNKNOWN
LABELING; Labeling	SUPPL	11	AP	2014-11-26	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-03-09	STANDARD
EFFICACY; Efficacy	SUPPL	15	AP	2016-11-25	PRIORITY
LABELING; Labeling	SUPPL	19	AP	2020-04-30	STANDARD

Submissions Property Types

SUPPL	8	Null	7
SUPPL	11	Null	7
SUPPL	13	Null	6
SUPPL	15	Null	15
SUPPL	19	Null	6

TE Codes

001

Prescription

AB

CDER Filings

SANOFI

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            [companyName] => SANOFI
            [docInserts] => ["",""]
            [products] => [{"drugName":"RENVELA","activeIngredients":"SEVELAMER CARBONATE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/30\/2020","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022127s019,022318s021lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2016","submission":"SUPPL-15","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022127s015,022318s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022127s013,022318s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/26\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022127s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2011","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022318s003,022127s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022127lbl.pdf\"}]","notes":""}]
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            [supplements] => 
            [actionDate] => 2020-04-30
        )

)