Documents
Application Sponsors
ANDA 207873 | TEVA PHARMS USA | |
Marketing Status
Application Products
001 | CAPSULE, DELAYED RELEASE;ORAL | 400MG | 0 | MESALAMINE | MESALAMINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-05-09 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
TEVA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 207873
[companyName] => TEVA PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"400MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207873Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-05-09
)
)