Application Sponsors
Marketing Status
Application Products
| 001 | SUSPENSION;ORAL | 200MG/ML | 0 | MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2019-02-12 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-11-25 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2022-11-10 | STANDARD |
| REMS; REMS | SUPPL | 5 | AP | 2021-01-15 | |
| REMS; REMS | SUPPL | 8 | AP | 2021-04-21 | |
| REMS; REMS | SUPPL | 9 | AP | 2021-08-11 | |
| LABELING; Labeling | SUPPL | 11 | AP | 2022-11-10 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2022-11-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
TE Codes
CDER Filings
VISTAPHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 210370
[companyName] => VISTAPHARM
[docInserts] => ["",""]
[products] => [{"drugName":"MYCOPHENOLATE MOFETIL","activeIngredients":"MYCOPHENOLATE MOFETIL","strength":"200MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/21\/2021","submission":"SUPPL-8","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/15\/2021","submission":"SUPPL-5","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/25\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2021-04-21
)
)