Application 021462
- Type
- NDA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALIMTA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL | Yes | Yes |
| 002 | ALIMTA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 100MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0002-7623 | Alimta | Pemetrexed disodium | Eli Lilly and Company | NDA | Current |
| 0002-7623 | Alimta | Pemetrexed disodium | Eli Lilly and Company | NDA | Current |
| 0002-7623 | Alimta | Pemetrexed disodium | Eli Lilly and Company | NDA | Current |
| 0002-7623 | Alimta | Pemetrexed disodium | Eli Lilly and Company | NDA | Current |
| 0002-7623 | Alimta | Pemetrexed disodium | Eli Lilly and Company | NDA | Current |
| 0002-7640 | Alimta | Pemetrexed disodium | Eli Lilly and Company | NDA | Current |
| 0002-7640 | Alimta | Pemetrexed disodium | Eli Lilly and Company | NDA | Current |
| 0002-7640 | Alimta | Pemetrexed disodium | Eli Lilly and Company | NDA | Current |
| 0002-7640 | Alimta | Pemetrexed disodium | Eli Lilly and Company | NDA | Current |
| 0002-7640 | Alimta | Pemetrexed disodium | Eli Lilly and Company | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71992 | SUPPL | 2022-09-01 |
| 71987 | SUPPL | 2022-09-01 |
| 65711 | SUPPL | 2020-12-23 |
| 57520 | SUPPL | 2019-02-13 |
| 57393 | SUPPL | 2019-01-31 |
| 54438 | SUPPL | 2018-06-05 |
| 54436 | SUPPL | 2018-06-05 |
| 53756 | SUPPL | 2018-04-20 |
| 50020 | SUPPL | 2017-10-12 |
| 50019 | SUPPL | 2017-10-12 |
| 15534 | SUPPL | 2013-09-17 |
| 5456 | SUPPL | 2013-09-13 |
| 37004 | SUPPL | 2013-01-22 |
| 37005 | SUPPL | 2012-11-15 |
| 27862 | SUPPL | 2012-11-14 |
| 5455 | SUPPL | 2012-10-18 |
| 15532 | SUPPL | 2012-10-17 |
| 27861 | SUPPL | 2012-06-07 |
| 15533 | SUPPL | 2012-06-05 |
| 37002 | SUPPL | 2011-11-25 |
| 15531 | SUPPL | 2011-11-25 |
| 37001 | SUPPL | 2011-11-23 |
| 27860 | SUPPL | 2011-11-22 |
| 5453 | SUPPL | 2011-11-22 |
| 5452 | SUPPL | 2011-11-22 |
| 42180 | SUPPL | 2011-09-22 |
| 5454 | SUPPL | 2011-03-23 |
| 37003 | SUPPL | 2011-03-21 |
| 37000 | SUPPL | 2009-07-09 |
| 15530 | SUPPL | 2009-07-09 |
| 27859 | SUPPL | 2009-07-08 |
| 27858 | SUPPL | 2009-07-08 |
| 5451 | SUPPL | 2009-07-08 |
| 36999 | SUPPL | 2009-07-06 |
| 27857 | SUPPL | 2008-10-01 |
| 36998 | SUPPL | 2008-09-26 |
| 27856 | SUPPL | 2007-09-11 |
| 15529 | SUPPL | 2007-09-11 |
| 36997 | SUPPL | 2007-02-21 |
| 27855 | SUPPL | 2007-02-12 |
| 27854 | SUPPL | 2006-08-04 |
| 15528 | SUPPL | 2006-08-04 |
| 23664 | ORIG | 2005-04-15 |
| 5450 | SUPPL | 2004-08-25 |
| 15527 | SUPPL | 2004-08-19 |
| 42179 | ORIG | 2004-03-28 |
| 44477 | ORIG | 2004-02-05 |
| 36996 | ORIG | 2004-02-05 |
| 23073 | ORIG | 2004-02-05 |
| 5449 | ORIG | 2004-02-05 |
| 64046 | ORIG | 1900-01-01 |
| 64045 | ORIG | 1900-01-01 |
| 64044 | ORIG | 1900-01-01 |
| 58112 | ORIG | 1900-01-01 |
| 53391 | ORIG | 1900-01-01 |
| 53390 | ORIG | 1900-01-01 |
| 53389 | ORIG | 1900-01-01 |