Application 021035
- Type
- NDA
- Sponsor
- UCB INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KEPPRA | LEVETIRACETAM | TABLET;ORAL | 250MG | Yes | No |
| 002 | KEPPRA | LEVETIRACETAM | TABLET;ORAL | 500MG | Yes | No |
| 003 | KEPPRA | LEVETIRACETAM | TABLET;ORAL | 750MG | Yes | No |
| 004 | KEPPRA | LEVETIRACETAM | TABLET;ORAL | 1GM | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-070 | Keppra | levetiracetam | Rebel Distributors Corp | NDA | Current |
| 50474-594 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-594 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-594 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-594 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-595 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-595 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-595 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-595 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-596 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-596 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-596 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-596 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-597 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-597 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-597 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 50474-597 | Keppra | levetiracetam | UCB, Inc. | NDA | Current |
| 55289-097 | Keppra | levetiracetam | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-097 | Keppra | levetiracetam | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-097 | Keppra | levetiracetam | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-097 | Keppra | levetiracetam | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-097 | Keppra | levetiracetam | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-097 | Keppra | levetiracetam | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 65084-457 | Keppra | levetiracetam | Mckesson Rxpak Inc | NDA | Current |
| 65084-458 | Keppra | levetiracetam | Mckesson Rxpak Inc | NDA | Current |
| 65084-459 | Keppra | levetiracetam | Mckesson Rxpak Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77817 | SUPPL | 2024-03-13 |
| 77796 | SUPPL | 2024-03-13 |
| 77795 | SUPPL | 2024-03-13 |
| 75350 | SUPPL | 2023-09-05 |
| 75341 | SUPPL | 2023-09-01 |
| 75136 | SUPPL | 2023-08-18 |
| 75118 | SUPPL | 2023-08-18 |
| 72411 | SUPPL | 2022-10-19 |
| 64806 | SUPPL | 2020-10-02 |
| 64805 | SUPPL | 2020-10-02 |
| 64778 | SUPPL | 2020-10-01 |
| 60652 | SUPPL | 2019-10-24 |
| 60644 | SUPPL | 2019-10-24 |
| 60643 | SUPPL | 2019-10-24 |
| 50216 | SUPPL | 2017-10-30 |
| 50210 | SUPPL | 2017-10-27 |
| 48146 | SUPPL | 2017-04-27 |
| 48108 | SUPPL | 2017-04-25 |
| 45766 | SUPPL | 2016-11-01 |
| 45706 | SUPPL | 2016-10-28 |
| 26543 | SUPPL | 2015-03-12 |
| 14213 | SUPPL | 2015-03-12 |
| 26544 | SUPPL | 2014-08-11 |
| 35942 | SUPPL | 2014-08-08 |
| 4114 | SUPPL | 2014-03-11 |
| 14212 | SUPPL | 2014-03-10 |
| 14211 | SUPPL | 2013-07-30 |
| 4113 | SUPPL | 2013-07-26 |
| 26541 | SUPPL | 2011-12-21 |
| 26540 | SUPPL | 2011-12-21 |
| 26537 | SUPPL | 2011-12-21 |
| 4112 | SUPPL | 2011-12-21 |
| 4109 | SUPPL | 2011-12-21 |
| 35941 | SUPPL | 2011-12-20 |
| 35940 | SUPPL | 2011-12-20 |
| 35938 | SUPPL | 2011-12-20 |
| 14210 | SUPPL | 2011-12-20 |
| 14207 | SUPPL | 2011-12-20 |
| 26542 | SUPPL | 2011-08-12 |
| 14209 | SUPPL | 2009-05-13 |
| 14208 | SUPPL | 2009-05-13 |
| 4111 | SUPPL | 2009-05-04 |
| 4110 | SUPPL | 2009-05-04 |
| 52946 | SUPPL | 2008-06-03 |
| 52944 | SUPPL | 2008-06-03 |
| 52943 | SUPPL | 2008-06-03 |
| 52311 | SUPPL | 2008-06-03 |
| 52310 | SUPPL | 2008-06-03 |
| 52309 | SUPPL | 2008-06-03 |
| 52308 | SUPPL | 2008-06-03 |
| 52307 | SUPPL | 2008-06-03 |
| 52306 | SUPPL | 2008-06-03 |
| 4108 | SUPPL | 2007-09-25 |
| 23618 | ORIG | 2007-03-28 |
| 26539 | SUPPL | 2007-03-23 |
| 14206 | SUPPL | 2007-03-23 |
| 35939 | SUPPL | 2006-08-18 |
| 26538 | SUPPL | 2006-08-18 |
| 14205 | SUPPL | 2006-08-18 |
| 4107 | SUPPL | 2006-08-18 |
| 4105 | SUPPL | 2006-01-30 |
| 26536 | SUPPL | 2006-01-20 |
| 35937 | SUPPL | 2005-06-23 |
| 4106 | SUPPL | 2005-06-23 |
| 4104 | SUPPL | 2004-10-29 |
| 4103 | SUPPL | 2004-10-29 |
| 4102 | SUPPL | 2003-09-09 |
| 4101 | SUPPL | 2002-05-22 |
| 4100 | SUPPL | 2002-05-22 |
| 41891 | ORIG | 1999-11-30 |
| 14204 | ORIG | 1999-11-30 |
| 4099 | ORIG | 1999-11-30 |
| 63936 | ORIG | 1900-01-01 |
| 63935 | ORIG | 1900-01-01 |
| 63934 | ORIG | 1900-01-01 |
| 63933 | ORIG | 1900-01-01 |
| 63932 | ORIG | 1900-01-01 |
| 63931 | ORIG | 1900-01-01 |
| 52000 | SUPPL | 1900-01-01 |
| 51999 | SUPPL | 1900-01-01 |
| 51998 | SUPPL | 1900-01-01 |
| 51997 | SUPPL | 1900-01-01 |
| 51996 | SUPPL | 1900-01-01 |