Application 018082
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEPAKENE | VALPROIC ACID | SYRUP;ORAL | 250MG/5ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-5682 | Depakene | Valproic Acid | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63337 | SUPPL | 2020-05-29 |
| 63158 | SUPPL | 2020-05-20 |
| 61068 | SUPPL | 2019-11-26 |
| 61057 | SUPPL | 2019-11-26 |
| 57783 | SUPPL | 2019-02-22 |
| 57761 | SUPPL | 2019-02-22 |
| 56338 | SUPPL | 2018-11-08 |
| 54086 | SUPPL | 2018-05-10 |
| 54066 | SUPPL | 2018-05-10 |
| 49999 | SUPPL | 2017-10-10 |
| 49984 | SUPPL | 2017-10-06 |
| 47508 | SUPPL | 2017-03-08 |
| 47480 | SUPPL | 2017-03-07 |
| 45841 | SUPPL | 2016-11-08 |
| 45811 | SUPPL | 2016-11-04 |
| 14030 | SUPPL | 2016-02-23 |
| 11155 | SUPPL | 2016-02-23 |
| 11154 | SUPPL | 2015-10-06 |
| 835 | SUPPL | 2015-09-25 |
| 11153 | SUPPL | 2015-03-17 |
| 834 | SUPPL | 2015-03-17 |
| 33431 | SUPPL | 2015-01-08 |
| 832 | SUPPL | 2015-01-08 |
| 33430 | SUPPL | 2014-12-03 |
| 14028 | SUPPL | 2014-11-24 |
| 11152 | SUPPL | 2014-08-22 |
| 14029 | SUPPL | 2014-08-21 |
| 33425 | SUPPL | 2014-06-23 |
| 829 | SUPPL | 2014-06-23 |
| 833 | SUPPL | 2014-06-11 |
| 11151 | SUPPL | 2014-06-10 |
| 11150 | SUPPL | 2013-09-17 |
| 831 | SUPPL | 2013-09-17 |
| 33429 | SUPPL | 2013-07-02 |
| 33428 | SUPPL | 2013-03-04 |
| 14027 | SUPPL | 2013-03-01 |
| 14026 | SUPPL | 2011-10-13 |
| 14024 | SUPPL | 2011-10-13 |
| 830 | SUPPL | 2011-10-13 |
| 828 | SUPPL | 2011-10-13 |
| 33427 | SUPPL | 2011-10-12 |
| 33426 | SUPPL | 2011-10-12 |
| 11149 | SUPPL | 2011-10-12 |
| 11148 | SUPPL | 2011-10-12 |
| 33424 | SUPPL | 2009-05-12 |
| 14025 | SUPPL | 2009-05-01 |
| 44019 | ORIG | 2008-02-01 |
| 14023 | SUPPL | 2006-10-23 |
| 33423 | SUPPL | 2006-10-18 |
| 827 | SUPPL | 2006-01-20 |
| 33422 | SUPPL | 2006-01-13 |
| 826 | SUPPL | 2004-06-02 |