Documents
Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | 1MG/ML | 1 | RAPAMUNE | SIROLIMUS |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1999-09-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2000-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2000-08-25 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2003-01-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2003-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2003-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2003-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2003-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2003-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2003-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2003-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2003-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2004-07-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2005-03-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 20 | AP | 2005-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2005-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2005-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2005-10-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 2006-06-02 | UNKNOWN |
| LABELING; Labeling | SUPPL | 25 | AP | 2006-06-02 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2007-01-09 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2006-10-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2007-01-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 30 | AP | 2007-01-12 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2007-05-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 33 | AP | 2008-01-14 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2007-10-17 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2008-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2008-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2009-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2009-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2009-10-08 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 42 | AP | 2010-04-22 | UNKNOWN |
| LABELING; Labeling | SUPPL | 43 | AP | 2010-04-22 | UNKNOWN |
| LABELING; Labeling | SUPPL | 44 | AP | 2010-11-23 | UNKNOWN |
| LABELING; Labeling | SUPPL | 45 | AP | 2010-01-25 | UNKNOWN |
| LABELING; Labeling | SUPPL | 46 | AP | 2010-07-02 | UNKNOWN |
| LABELING; Labeling | SUPPL | 47 | AP | 2010-11-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 48 | AP | 2010-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2011-07-11 | UNKNOWN |
| REMS; REMS | SUPPL | 50 | AP | 2011-06-06 | N/A |
| LABELING; Labeling | SUPPL | 51 | AP | 2012-12-10 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2013-03-07 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2013-05-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 55 | AP | 2015-05-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 56 | AP | 2015-03-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 2015-07-31 | PRIORITY |
| LABELING; Labeling | SUPPL | 58 | AP | 2015-11-05 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2017-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 61 | AP | 2018-05-23 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2018-01-12 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2019-07-15 | STANDARD |
| LABELING; Labeling | SUPPL | 65 | AP | 2019-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 66 | AP | 2019-06-18 | STANDARD |
| LABELING; Labeling | SUPPL | 67 | AP | 2020-01-02 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 2022-08-22 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 2022-08-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 25 |
| SUPPL | 17 | Null | 9 |
| SUPPL | 19 | Null | 26 |
| SUPPL | 28 | Null | 9 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 41 | Null | 6 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 44 | Null | 6 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 46 | Null | 6 |
| SUPPL | 47 | Null | 6 |
| SUPPL | 48 | Null | 6 |
| SUPPL | 49 | Null | 6 |
| SUPPL | 50 | Null | 6 |
| SUPPL | 51 | Null | 6 |
| SUPPL | 53 | Null | 15 |
| SUPPL | 54 | Null | 6 |
| SUPPL | 55 | Null | 6 |
| SUPPL | 56 | Null | 7 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 58 | Null | 6 |
| SUPPL | 59 | Null | 6 |
| SUPPL | 61 | Null | 15 |
| SUPPL | 62 | Null | 6 |
| SUPPL | 64 | Null | 15 |
| SUPPL | 65 | Null | 6 |
| SUPPL | 66 | Null | 7 |
| SUPPL | 67 | Null | 7 |
| SUPPL | 69 | Null | 7 |
| SUPPL | 70 | Null | 31 |
TE Codes
CDER Filings
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