NDA 205266

SUN PHARMA GLOBAL

FDA Drug Application

Application #205266

Documents

• Letter: 2016-05-16
• Label: 2016-05-17
• Review: 2015-08-28
• Letter: 2015-07-24
• Label: 2015-07-24
• Label: 2016-03-30
• Medication Guide: 2017-01-03
• Label: 2017-09-19
• Letter: 2017-09-22
• Label: 2019-05-14
• Medication Guide: 2019-05-14
• Letter: 2019-05-15
• Medication Guide: 2019-06-17

Application Sponsors

NDA 205266

SUN PHARMA GLOBAL

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 200MG BASE

1

ODOMZO

SONIDEGIB PHOSPHATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2015-07-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2016-05-12	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-02-17	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2017-09-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-05-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	7

CDER Filings

SUN PHARMA GLOBAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205266
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/205266s006lbl.pdf#page=13"]
            [products] => [{"drugName":"ODOMZO","activeIngredients":"SONIDEGIB PHOSPHATE","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/13\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205266s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2017","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205266s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205266s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205266s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205266Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/24\/2015","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\\\/2015\\\/205266Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205266Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/205266Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/13\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205266s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205266Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2017","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205266s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205266Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"02\/17\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205266s003lbl.pdf\"}]","notes":">"},{"actionDate":"05\/12\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205266s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205266Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-05-13
        )

)