Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, DELAYED RELEASE;ORAL | 180MG | 1 | MYFORTIC | MYCOPHENOLIC ACID |
| 002 | TABLET, DELAYED RELEASE;ORAL | 360MG | 1 | MYFORTIC | MYCOPHENOLIC ACID |
FDA Submissions
| TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | AP | 2004-02-27 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2008-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2008-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2012-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2009-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2009-07-10 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2009-10-08 | UNKNOWN |
| LABELING; Labeling | SUPPL | 11 | AP | 2010-10-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 12 | AP | 2013-05-01 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2012-06-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2013-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2013-05-01 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2013-09-27 | STANDARD |
| REMS; REMS | SUPPL | 19 | AP | 2013-09-27 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2015-08-04 | STANDARD |
| REMS; REMS | SUPPL | 22 | AP | 2015-11-13 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2015-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2015-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2020-04-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2020-11-03 | N/A |
| REMS; REMS | SUPPL | 33 | AP | 2021-01-15 | N/A |
| REMS; REMS | SUPPL | 34 | AP | 2021-04-21 | N/A |
| LABELING; Labeling | SUPPL | 35 | AP | 2022-03-15 | STANDARD |
| REMS; REMS | SUPPL | 36 | AP | 2021-08-11 | N/A |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 33 | Null | 6 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 35 | Null | 7 |
| SUPPL | 36 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 50791
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)