Application 020592
- Type
- NDA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZYPREXA | OLANZAPINE | TABLET;ORAL | 2.5MG | Yes | No |
| 002 | ZYPREXA | OLANZAPINE | TABLET;ORAL | 5MG | Yes | Yes |
| 003 | ZYPREXA | OLANZAPINE | TABLET;ORAL | 7.5MG | Yes | No |
| 004 | ZYPREXA | OLANZAPINE | TABLET;ORAL | 10MG | Yes | No |
| 005 | ZYPREXA | OLANZAPINE | TABLET;ORAL | 15MG | Yes | No |
| 006 | ZYPREXA | OLANZAPINE | TABLET;ORAL | 20MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0002-4112 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4112 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4112 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4112 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4112 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4112 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4115 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4115 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4115 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4115 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4115 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4115 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4116 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4116 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4116 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4116 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4116 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4116 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4117 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4117 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4117 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4117 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4117 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4117 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4415 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4415 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4415 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4415 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4415 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4415 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4420 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4420 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4420 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4420 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4420 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4420 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 21695-140 | Zyprexa | Olanzapine | Rebel Distributors Corp | NDA | Current |
| 21695-142 | Zyprexa | Olanzapine | Rebel Distributors Corp | NDA | Current |
| 21695-144 | Zyprexa | Olanzapine | Rebel Distributors Corp | NDA | Current |
| 49999-606 | Zyprexa | Olanzapine | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 52959-579 | Zyprexa | Olanzapine | H.J. Harkins Company, Inc. | NDA | Current |
| 55289-213 | Zyprexa | Olanzapine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 68258-7090 | Zyprexa | Olanzapine | Dispensing Solutions, Inc. | NDA | Current |
| 68258-7091 | Zyprexa | Olanzapine | Dispensing Solutions, Inc. | NDA | Current |
| 68258-7092 | Zyprexa | Olanzapine | Dispensing Solutions, Inc. | NDA | Current |
| 68258-7093 | Zyprexa | Olanzapine | Dispensing Solutions, Inc. | NDA | Current |
| 70518-1465 | Zyprexa | Olanzapine | REMEDYREPACK INC. | NDA | Current |
| 70518-1465 | Zyprexa | Olanzapine | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84950 | SUPPL | 2026-02-05 |
| 84889 | SUPPL | 2026-02-03 |
| 84951 | SUPPL | 2026-01-30 |
| 81159 | SUPPL | 2025-02-07 |
| 80957 | SUPPL | 2025-02-05 |
| 62676 | SUPPL | 2020-04-24 |
| 62663 | SUPPL | 2020-04-24 |
| 62662 | SUPPL | 2020-04-24 |
| 62635 | SUPPL | 2020-04-22 |
| 62634 | SUPPL | 2020-04-22 |
| 62629 | SUPPL | 2020-04-22 |
| 60660 | SUPPL | 2019-10-24 |
| 60657 | SUPPL | 2019-10-24 |
| 60635 | SUPPL | 2019-10-23 |
| 53520 | SUPPL | 2018-03-29 |
| 53472 | SUPPL | 2018-03-28 |
| 47377 | SUPPL | 2017-03-02 |
| 47376 | SUPPL | 2017-03-02 |
| 47347 | SUPPL | 2017-02-27 |
| 47346 | SUPPL | 2017-02-27 |
| 45532 | SUPPL | 2016-10-14 |
| 45600 | SUPPL | 2016-10-07 |
| 34914 | SUPPL | 2015-07-24 |
| 12799 | SUPPL | 2015-01-09 |
| 2817 | SUPPL | 2014-12-23 |
| 12800 | SUPPL | 2013-07-30 |
| 2818 | SUPPL | 2013-07-30 |
| 41458 | SUPPL | 2012-03-16 |
| 41457 | SUPPL | 2012-03-16 |
| 41455 | SUPPL | 2012-03-16 |
| 20747 | SUPPL | 2012-03-16 |
| 20749 | SUPPL | 2012-01-27 |
| 44059 | ORIG | 2011-12-22 |
| 41456 | SUPPL | 2011-06-30 |
| 20748 | SUPPL | 2011-06-30 |
| 34913 | SUPPL | 2011-06-29 |
| 12798 | SUPPL | 2011-06-29 |
| 25267 | SUPPL | 2011-06-27 |
| 25266 | SUPPL | 2011-06-27 |
| 44452 | SUPPL | 2011-01-07 |
| 25265 | SUPPL | 2010-12-06 |
| 12797 | SUPPL | 2010-12-04 |
| 34912 | SUPPL | 2010-06-03 |
| 34911 | SUPPL | 2010-06-03 |
| 25264 | SUPPL | 2010-06-03 |
| 2816 | SUPPL | 2010-06-03 |
| 25263 | SUPPL | 2010-02-01 |
| 34910 | SUPPL | 2010-01-29 |
| 25260 | SUPPL | 2010-01-26 |
| 2813 | SUPPL | 2010-01-26 |
| 12794 | SUPPL | 2009-12-10 |
| 12793 | SUPPL | 2009-12-10 |
| 25262 | SUPPL | 2009-11-19 |
| 34909 | SUPPL | 2009-09-17 |
| 20746 | SUPPL | 2009-09-16 |
| 20745 | SUPPL | 2009-09-16 |
| 34908 | SUPPL | 2009-03-20 |
| 2815 | SUPPL | 2008-08-19 |
| 20743 | ORIG | 2007-11-19 |
| 25261 | SUPPL | 2007-07-10 |
| 12796 | SUPPL | 2007-07-10 |
| 12795 | SUPPL | 2007-07-10 |
| 2814 | SUPPL | 2007-07-10 |
| 41454 | SUPPL | 2007-07-06 |
| 20744 | SUPPL | 2007-04-11 |
| 25259 | SUPPL | 2006-12-28 |
| 34907 | SUPPL | 2006-12-04 |
| 2809 | SUPPL | 2006-09-18 |
| 34905 | SUPPL | 2006-08-29 |
| 2812 | SUPPL | 2006-03-01 |
| 34906 | SUPPL | 2006-02-28 |
| 25258 | SUPPL | 2006-02-22 |
| 12792 | SUPPL | 2006-02-22 |
| 12791 | SUPPL | 2006-02-22 |
| 2810 | SUPPL | 2006-02-22 |
| 2811 | SUPPL | 2005-09-15 |
| 25257 | SUPPL | 2005-08-08 |
| 25256 | SUPPL | 2005-06-29 |
| 41453 | SUPPL | 2004-04-15 |
| 12790 | SUPPL | 2004-01-22 |
| 2808 | SUPPL | 2004-01-22 |
| 2807 | SUPPL | 2003-07-28 |
| 34904 | SUPPL | 2003-07-10 |
| 52115 | SUPPL | 1900-01-01 |
| 52114 | SUPPL | 1900-01-01 |
| 52113 | SUPPL | 1900-01-01 |
| 52111 | SUPPL | 1900-01-01 |
| 52110 | SUPPL | 1900-01-01 |
| 52109 | SUPPL | 1900-01-01 |