NDA 210308

SUN PHARMA GLOBAL

FDA Drug Application

Application #210308

Documents

• Label: 2018-05-23
• Letter: 2018-05-24
• Review: 2018-10-11
• Letter: 2020-09-18
• Label: 2020-09-18
• Letter: 2022-02-01
• Label: 2022-02-01
• Letter: 2022-03-25
• Label: 2022-03-25

Application Sponsors

NDA 210308

SUN PHARMA GLOBAL

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

125MG

1

YONSA

ABIRATERONE ACETATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-05-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-01-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-03-24	STANDARD

Submissions Property Types

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

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARMA GLOBAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210308
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"YONSA","activeIngredients":"ABIRATERONE ACETATE","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/17\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210308s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210308s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/22\/2018","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\\\/2018\\\/210308s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210308Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210308Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/17\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210308s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210308Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-09-17
        )

)