Application Sponsors
| ANDA 212087 | CONCORD BIOTECH LTD | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG | 0 | MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2020-07-31 | STANDARD |
| REMS; REMS | SUPPL | 2 | AP | 2021-01-15 | |
| REMS; REMS | SUPPL | 3 | AP | 2021-04-21 | |
| REMS; REMS | SUPPL | 4 | AP | 2021-08-11 | |
| LABELING; Labeling | SUPPL | 9 | AP | 2022-11-16 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 9 | Null | 7 |
TE Codes
CDER Filings
CONCORD BIOTECH LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 212087
[companyName] => CONCORD BIOTECH LTD
[docInserts] => ["",""]
[products] => [{"drugName":"MYCOPHENOLATE MOFETIL","activeIngredients":"MYCOPHENOLATE MOFETIL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MYCOPHENOLATE MOFETIL","submission":"MYCOPHENOLATE MOFETIL","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)