Documents
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
)
)