Application 020427
- Type
- NDA
- Sponsor
- LUNDBECK PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SABRIL | VIGABATRIN | TABLET;ORAL | 500MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67386-111 | SABRIL | vigabatrin | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-111 | SABRIL | vigabatrin | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-111 | SABRIL | vigabatrin | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-111 | SABRIL | vigabatrin | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-111 | SABRIL | vigabatrin | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-111 | SABRIL | vigabatrin | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-111 | SABRIL | vigabatrin | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-111 | SABRIL | vigabatrin | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-111 | SABRIL | vigabatrin | Lundbeck Pharmaceuticals LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85435 | SUPPL | 2026-03-20 |
| 79609 | SUPPL | 2024-09-16 |
| 72319 | SUPPL | 2022-10-13 |
| 69062 | SUPPL | 2021-10-21 |
| 69048 | SUPPL | 2021-10-21 |
| 69047 | SUPPL | 2021-10-21 |
| 64967 | SUPPL | 2020-10-21 |
| 64827 | SUPPL | 2020-10-05 |
| 61698 | SUPPL | 2020-01-27 |
| 61670 | SUPPL | 2020-01-27 |
| 59996 | SUPPL | 2019-09-13 |
| 59556 | SUPPL | 2019-08-02 |
| 59553 | SUPPL | 2019-08-02 |
| 59540 | SUPPL | 2019-08-01 |
| 58910 | SUPPL | 2019-06-03 |
| 55320 | SUPPL | 2018-08-27 |
| 55282 | SUPPL | 2018-08-23 |
| 55279 | SUPPL | 2018-08-23 |
| 50213 | SUPPL | 2017-10-30 |
| 48226 | SUPPL | 2017-05-02 |
| 48197 | SUPPL | 2017-05-02 |
| 12575 | SUPPL | 2016-06-27 |
| 24959 | SUPPL | 2016-06-23 |
| 34646 | SUPPL | 2015-09-23 |
| 24960 | SUPPL | 2015-09-23 |
| 34645 | SUPPL | 2014-04-04 |
| 24958 | SUPPL | 2014-04-04 |
| 34644 | SUPPL | 2013-10-31 |
| 12574 | SUPPL | 2013-10-31 |
| 12573 | SUPPL | 2013-10-31 |
| 24957 | SUPPL | 2013-10-29 |
| 2531 | SUPPL | 2013-10-29 |
| 2530 | SUPPL | 2013-10-29 |
| 34643 | SUPPL | 2012-12-14 |
| 24956 | SUPPL | 2012-12-13 |
| 44448 | ORIG | 2011-02-02 |
| 34642 | SUPPL | 2011-01-25 |
| 24955 | SUPPL | 2011-01-24 |
| 41355 | ORIG | 2009-11-23 |
| 34641 | ORIG | 2009-08-26 |
| 24954 | ORIG | 2009-08-26 |
| 52390 | ORIG | 1900-01-01 |
| 52388 | ORIG | 1900-01-01 |
| 51569 | ORIG | 1900-01-01 |
| 51568 | ORIG | 1900-01-01 |
| 51567 | ORIG | 1900-01-01 |