Documents
Application Sponsors
Marketing Status
Application Products
001 | SUPPOSITORY;RECTAL | 1GM | 0 | MESALAMINE | MESALAMINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-02-12 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2022-10-28 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2022-10-28 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 3 | Null | 7 |
SUPPL | 5 | Null | 7 |
TE Codes
CDER Filings
ZYDUS PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 208953
[companyName] => ZYDUS PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"1GM","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/12\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208953Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-02-12
)
)