Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
Application Products
| 001 | CAPSULE;ORAL | 80MG | 1 | EMEND | APREPITANT |
| 002 | CAPSULE;ORAL | 125MG | 1 | EMEND | APREPITANT |
| 003 | CAPSULE;ORAL | 40MG | 1 | EMEND | APREPITANT |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2003-03-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2004-01-15 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2004-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2004-12-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2005-10-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 9 | AP | 2005-06-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2006-06-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 11 | AP | 2006-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2007-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2009-07-21 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2008-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2009-02-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2010-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2013-03-20 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2012-07-06 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2013-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2014-08-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2015-08-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2015-01-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 27 | AP | 2017-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2019-11-14 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2019-09-25 | STANDARD |
Submissions Property Types
| SUPPL | 17 | Null | 31 |
| SUPPL | 19 | Null | 31 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 31 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21549
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)