Application Sponsors
| ANDA 211173 | CONCORD BIOTECH LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, DELAYED RELEASE;ORAL | 180MG | 0 | MYCOPHENOLIC ACID | MYCOPHENOLIC ACID |
| 002 | TABLET, DELAYED RELEASE;ORAL | 360MG | 0 | MYCOPHENOLIC ACID | MYCOPHENOLIC ACID |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2019-12-13 | STANDARD |
| REMS; REMS | SUPPL | 4 | AP | 2021-01-15 | |
| REMS; REMS | SUPPL | 6 | AP | 2021-04-21 | |
| REMS; REMS | SUPPL | 7 | AP | 2021-08-11 | |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
CONCORD BIOTECH LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 211173
[companyName] => CONCORD BIOTECH LTD
[docInserts] => ["",""]
[products] => [{"drugName":"MYCOPHENOLIC ACID","activeIngredients":"MYCOPHENOLIC ACID","strength":"180MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MYCOPHENOLIC ACID","activeIngredients":"MYCOPHENOLIC ACID","strength":"360MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/13\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-12-13
)
)