Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL | 1 | ALIMTA | PEMETREXED DISODIUM |
| 002 | POWDER;INTRAVENOUS | EQ 100MG BASE/VIAL | 1 | ALIMTA | PEMETREXED DISODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2004-02-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 2006-07-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2007-02-02 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2007-09-07 | N/A |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2008-09-26 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2009-07-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2009-07-02 | UNKNOWN |
| LABELING; Labeling | SUPPL | 22 | AP | 2009-07-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2011-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2011-11-18 | UNKNOWN |
| LABELING; Labeling | SUPPL | 32 | AP | 2011-11-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 33 | AP | 2011-03-17 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 39 | AP | 2012-10-17 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2012-06-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2013-03-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2013-01-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 43 | AP | 2012-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2013-09-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 2014-08-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 2016-01-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 50 | AP | 2017-10-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 51 | AP | 2018-06-04 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2018-04-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 53 | AP | 2019-01-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 55 | AP | 2022-08-31 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 32 | Null | 7 |
| SUPPL | 33 | Null | 8 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 41 | Null | 14 |
| SUPPL | 42 | Null | 14 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 45 | Null | 15 |
| SUPPL | 47 | Null | 14 |
| SUPPL | 49 | Null | 14 |
| SUPPL | 50 | Null | 7 |
| SUPPL | 51 | Null | 7 |
| SUPPL | 52 | Null | 15 |
| SUPPL | 53 | Null | 7 |
| SUPPL | 55 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21462
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)