Application Sponsors
| ANDA 210181 | CONCORD BIOTECH LTD | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 250MG | 0 | MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2019-01-08 | STANDARD |
| REMS; REMS | SUPPL | 6 | AP | 2021-01-15 | |
| REMS; REMS | SUPPL | 8 | AP | 2021-04-21 | |
| REMS; REMS | SUPPL | 9 | AP | 2021-08-11 | |
| LABELING; Labeling | SUPPL | 15 | AP | 2022-11-16 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 15 | Null | 7 |
TE Codes
CDER Filings
CONCORD BIOTECH LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 210181
[companyName] => CONCORD BIOTECH LTD
[docInserts] => ["",""]
[products] => [{"drugName":"MYCOPHENOLATE MOFETIL","activeIngredients":"MYCOPHENOLATE MOFETIL","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/25\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-25
)
)