Application Sponsors
Marketing Status
Application Products
001 | TABLET, DELAYED RELEASE;ORAL | 1.2GM | 0 | MESALAMINE | MESALAMINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-01-25 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2021-03-22 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2021-03-22 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2021-03-22 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 15 |
SUPPL | 5 | Null | 15 |
SUPPL | 6 | Null | 15 |
TE Codes
CDER Filings
SUN PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 211858
[companyName] => SUN PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"1.2GM","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/25\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/19\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-05-19
)
)