Application 018081
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEPAKENE | VALPROIC ACID | CAPSULE;ORAL | 250MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-5681 | Depakene | Valproic Acid | AbbVie Inc. | NDA | Current |
| 70518-1459 | Depakene | Valproic Acid | REMEDYREPACK INC. | NDA | Current |
| 70518-1459 | Depakene | Valproic Acid | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63202 | SUPPL | 2020-05-20 |
| 61067 | SUPPL | 2019-11-26 |
| 61066 | SUPPL | 2019-11-26 |
| 61056 | SUPPL | 2019-11-26 |
| 57782 | SUPPL | 2019-02-22 |
| 57760 | SUPPL | 2019-02-22 |
| 54085 | SUPPL | 2018-05-10 |
| 54065 | SUPPL | 2018-05-10 |
| 49998 | SUPPL | 2017-10-10 |
| 49985 | SUPPL | 2017-10-06 |
| 47509 | SUPPL | 2017-03-08 |
| 47479 | SUPPL | 2017-03-07 |
| 45840 | SUPPL | 2016-11-08 |
| 45810 | SUPPL | 2016-11-04 |
| 33421 | SUPPL | 2016-02-23 |
| 825 | SUPPL | 2016-02-23 |
| 33420 | SUPPL | 2015-10-06 |
| 14022 | SUPPL | 2015-09-25 |
| 33419 | SUPPL | 2015-03-17 |
| 14021 | SUPPL | 2015-03-17 |
| 14019 | SUPPL | 2015-01-08 |
| 11146 | SUPPL | 2015-01-08 |
| 11145 | SUPPL | 2014-12-03 |
| 14018 | SUPPL | 2014-11-24 |
| 33418 | SUPPL | 2014-08-22 |
| 14020 | SUPPL | 2014-08-21 |
| 14014 | SUPPL | 2014-06-23 |
| 11141 | SUPPL | 2014-06-23 |
| 824 | SUPPL | 2014-06-11 |
| 11147 | SUPPL | 2014-06-10 |
| 14017 | SUPPL | 2013-09-17 |
| 11144 | SUPPL | 2013-09-17 |
| 33417 | SUPPL | 2013-07-02 |
| 33416 | SUPPL | 2013-03-04 |
| 14016 | SUPPL | 2013-03-01 |
| 14015 | SUPPL | 2011-10-13 |
| 14013 | SUPPL | 2011-10-13 |
| 823 | SUPPL | 2011-10-13 |
| 821 | SUPPL | 2011-10-13 |
| 33415 | SUPPL | 2011-10-12 |
| 33414 | SUPPL | 2011-10-12 |
| 11143 | SUPPL | 2011-10-12 |
| 11142 | SUPPL | 2011-10-12 |
| 822 | SUPPL | 2009-05-01 |
| 23540 | ORIG | 2008-02-01 |
| 14012 | SUPPL | 2006-10-23 |
| 33413 | SUPPL | 2006-10-18 |
| 14011 | SUPPL | 2006-01-20 |
| 33412 | SUPPL | 2006-01-13 |
| 820 | SUPPL | 2004-06-02 |