MYCOPHENOLATE MOFETIL | N050723 | ROCHE PALO ALTO LLC
16 active API suppliers hold Drug Master Files for this ingredient.
Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.
| Date | Submission | Document |
|---|---|---|
| Jun 30, 2025 | SUPPL -54 | View Letter (PDF) |
| Aug 14, 2024 | SUPPL -53 | View Letter (PDF) |
| Aug 11, 2022 | SUPPL -50 | View Letter (PDF) |
| Jun 7, 2022 | SUPPL -49 | View Letter (PDF) |
| Jun 7, 2022 | SUPPL -51 | View Letter (PDF) |
| Oct 25, 2021 | SUPPL -45 | View Letter (PDF) |
| Oct 25, 2021 | SUPPL -46 | View Letter (PDF) |
| Aug 12, 2021 | SUPPL -48 | View Letter (PDF) |
| Apr 23, 2021 | SUPPL -47 | View Letter (PDF) |
| Jan 19, 2021 | SUPPL -44 | View Letter (PDF) |
| Dec 17, 2019 | SUPPL -41 | View Letter (PDF) |
| Feb 28, 2019 | SUPPL -38 | View Letter (PDF) |
| Aug 24, 2018 | SUPPL -35 | View Letter (PDF) |
| Dec 27, 2017 | SUPPL -37 | View Letter (PDF) |
| Nov 19, 2015 | SUPPL -33 | View Letter (PDF) |
| Jul 14, 2015 | SUPPL -32 | View Letter (PDF) |
| Oct 1, 2013 | SUPPL -29 | View Letter (PDF) |
| Oct 1, 2013 | SUPPL -30 | View Letter (PDF) |
| Sep 27, 2012 | SUPPL -20 | View Letter (PDF) |
| Jun 26, 2012 | SUPPL -27 | View Letter (PDF) |
| Jun 12, 2012 | SUPPL -25 | View Letter (PDF) |
| Nov 20, 2009 | SUPPL -21 | View Letter (PDF) |
| Nov 9, 2009 | SUPPL -23 | View Letter (PDF) |
| Jun 23, 2009 | SUPPL -19 | View Letter (PDF) |
| Mar 5, 2009 | SUPPL -18 | View Letter (PDF) |
| Dec 24, 2008 | SUPPL -17 | View Letter (PDF) |
| May 15, 2008 | SUPPL -15 | View Letter (PDF) |
| Jan 9, 2008 | SUPPL -12 | View Letter (PDF) |
| Sep 25, 2007 | SUPPL -13 | View Letter (PDF) |
| Oct 19, 2005 | SUPPL -10 | View Letter (PDF) |
| Mar 10, 2003 | SUPPL -6 | View Letter (PDF) |
| Dec 22, 2000 | SUPPL -4 | View Letter (PDF) |
| Jul 28, 2000 | SUPPL -5 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.