Application Sponsors
ANDA 205654 | ACTAVIS MID ATLANTIC | |
Marketing Status
Application Products
001 | SUPPOSITORY;RECTAL | 1GM | 0 | MESALAMINE | MESALAMINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-08-14 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ACTAVIS MID ATLANTIC
cder:Array
(
[0] => Array
(
[ApplNo] => 205654
[companyName] => ACTAVIS MID ATLANTIC
[docInserts] => ["",""]
[products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"1GM","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-08-14
)
)