NDA 208647

SUN PHARMA GLOBAL

FDA Drug Application

Application #208647

Documents

• Label: 2018-12-19
• Letter: 2018-12-21
• Letter: 2019-03-29
• Label: 2019-04-02
• Review: 2019-08-09
• Letter: 2020-04-20
• Label: 2020-04-20
• Letter: 2020-09-28
• Label: 2020-09-29

Application Sponsors

NDA 208647

SUN PHARMA GLOBAL

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	EQ 5MG BASE	1	EZALLOR	ROSUVASTATIN CALCIUM
002	CAPSULE;ORAL	EQ 10MG BASE	1	EZALLOR	ROSUVASTATIN CALCIUM
003	CAPSULE;ORAL	EQ 20MG BASE	1	EZALLOR	ROSUVASTATIN CALCIUM
004	CAPSULE;ORAL	EQ 40MG BASE	1	EZALLOR	ROSUVASTATIN CALCIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-12-18	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-04-17	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-09-25	901 REQUIRED

Submissions Property Types

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

CDER Filings

SUN PHARMA GLOBAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208647
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"EZALLOR SPRINKLE","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"EZALLOR SPRINKLE","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"EZALLOR SPRINKLE","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"EZALLOR SPRINKLE","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"EQ 40MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/25\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208647s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208647s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208647s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208647s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208647s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208647s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208647s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/18\/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\\\/208647s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208647Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208647Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/25\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208647s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208647Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"04\/17\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208647s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208647Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"03\/27\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208647s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208647Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-09-25
        )

)