Application Sponsors
ANDA 212130 | NANJING KING-FRIEND | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 500MG/VIAL | 0 | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-01-15 | STANDARD |
REMS; REMS | SUPPL | 2 | AP | 2021-04-21 | |
REMS; REMS | SUPPL | 3 | AP | 2021-08-11 | |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 7 |
TE Codes
CDER Filings
NANJING KING-FRIEND
cder:Array
(
[0] => Array
(
[ApplNo] => 212130
[companyName] => NANJING KING-FRIEND
[docInserts] => ["",""]
[products] => [{"drugName":"MYCOPHENOLATE MOFETIL HYDROCHLORIDE","activeIngredients":"MYCOPHENOLATE MOFETIL HYDROCHLORIDE","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-01-15
)
)