NDA 211929

SUN PHARMA GLOBAL

FDA Drug Application

Application #211929

Documents

• Label: 2019-06-14
• Letter: 2019-06-17
• Review: 2020-01-24

Application Sponsors

NDA 211929

SUN PHARMA GLOBAL

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	6MG	1	ORTIKOS	BUDESONIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	9MG	1	ORTIKOS	BUDESONIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2019-06-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-06-29	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	8	Null	15

CDER Filings

SUN PHARMA GLOBAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211929
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORTIKOS","activeIngredients":"BUDESONIDE","strength":"6MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ORTIKOS","activeIngredients":"BUDESONIDE","strength":"9MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/13\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211929s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/13\/2019","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\\\/2019\\\/211929s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211929Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211929Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-06-13
        )

)