Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET, DELAYED RELEASE;ORAL | 20MG | 0 | OMEPRAZOLE | OMEPRAZOLE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-10-12 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2020-11-16 | STANDARD |
Submissions Property Types
CDER Filings
SUN PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 207891
[companyName] => SUN PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"20MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/12\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207891Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/16\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-11-16
)
)