Application 018723
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEPAKOTE | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 250MG VALPROIC ACID | Yes | No |
| 002 | DEPAKOTE | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 500MG VALPROIC ACID | Yes | Yes |
| 003 | DEPAKOTE | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 125MG VALPROIC ACID | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-6212 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6212 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6212 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6212 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6212 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6212 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6212 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6212 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6212 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6214 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6214 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6214 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6214 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6214 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6214 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6214 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6214 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6214 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6214 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6215 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6215 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6215 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6215 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6215 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6215 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6215 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6215 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6215 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-6215 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-7325 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-7325 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-7325 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-7327 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-7327 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 0074-7327 | Depakote | Divalproex Sodium | AbbVie Inc. | NDA | Current |
| 70518-1454 | Depakote | Divalproex Sodium | REMEDYREPACK INC. | NDA | Current |
| 70518-1454 | Depakote | Divalproex Sodium | REMEDYREPACK INC. | NDA | Current |
| 70518-1454 | Depakote | Divalproex Sodium | REMEDYREPACK INC. | NDA | Current |
| 70518-1456 | Depakote | Divalproex Sodium | REMEDYREPACK INC. | NDA | Current |
| 70518-1456 | Depakote | Divalproex Sodium | REMEDYREPACK INC. | NDA | Current |
| 70518-1456 | Depakote | Divalproex Sodium | REMEDYREPACK INC. | NDA | Current |
| 70518-1456 | Depakote | Divalproex Sodium | REMEDYREPACK INC. | NDA | Current |
| 70518-1456 | Depakote | Divalproex Sodium | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85626 | SUPPL | 2026-04-02 |
| 85621 | SUPPL | 2026-04-02 |
| 85665 | SUPPL | 2026-03-31 |
| 82131 | SUPPL | 2025-05-05 |
| 82171 | SUPPL | 2025-05-01 |
| 81056 | SUPPL | 2025-02-06 |
| 81045 | SUPPL | 2025-02-06 |
| 77907 | SUPPL | 2024-03-21 |
| 77875 | SUPPL | 2024-03-19 |
| 73672 | SUPPL | 2023-03-03 |
| 73612 | SUPPL | 2023-02-27 |
| 69463 | SUPPL | 2021-12-03 |
| 69462 | SUPPL | 2021-12-03 |
| 69436 | SUPPL | 2021-12-01 |
| 66256 | SUPPL | 2021-02-17 |
| 66255 | SUPPL | 2021-02-17 |
| 66197 | SUPPL | 2021-02-11 |
| 63200 | SUPPL | 2020-05-20 |
| 63199 | SUPPL | 2020-05-20 |
| 63159 | SUPPL | 2020-05-20 |
| 61064 | SUPPL | 2019-11-26 |
| 61063 | SUPPL | 2019-11-26 |
| 61058 | SUPPL | 2019-11-26 |
| 57779 | SUPPL | 2019-02-22 |
| 57762 | SUPPL | 2019-02-22 |
| 54087 | SUPPL | 2018-05-10 |
| 54067 | SUPPL | 2018-05-10 |
| 50000 | SUPPL | 2017-10-10 |
| 49983 | SUPPL | 2017-10-06 |
| 47507 | SUPPL | 2017-03-08 |
| 47478 | SUPPL | 2017-03-07 |
| 45845 | SUPPL | 2016-11-08 |
| 45812 | SUPPL | 2016-11-04 |
| 16014 | SUPPL | 2016-02-23 |
| 11306 | SUPPL | 2016-02-23 |
| 33579 | SUPPL | 2015-10-06 |
| 1051 | SUPPL | 2015-09-25 |
| 33578 | SUPPL | 2015-03-17 |
| 1050 | SUPPL | 2015-03-17 |
| 11304 | SUPPL | 2015-01-08 |
| 1049 | SUPPL | 2015-01-08 |
| 11303 | SUPPL | 2014-12-03 |
| 16011 | SUPPL | 2014-11-24 |
| 11305 | SUPPL | 2014-08-22 |
| 16013 | SUPPL | 2014-08-21 |
| 15121 | SUPPL | 2014-06-23 |
| 11297 | SUPPL | 2014-06-23 |
| 16012 | SUPPL | 2014-06-11 |
| 33577 | SUPPL | 2014-06-10 |
| 16010 | SUPPL | 2013-09-17 |
| 11302 | SUPPL | 2013-09-17 |
| 33576 | SUPPL | 2013-07-02 |
| 11301 | SUPPL | 2013-03-04 |
| 1048 | SUPPL | 2013-03-01 |
| 16009 | SUPPL | 2011-10-13 |
| 16008 | SUPPL | 2011-10-13 |
| 15120 | SUPPL | 2011-10-13 |
| 15118 | SUPPL | 2011-10-13 |
| 1047 | SUPPL | 2011-10-13 |
| 11300 | SUPPL | 2011-10-12 |
| 11299 | SUPPL | 2011-10-12 |
| 11298 | SUPPL | 2011-10-12 |
| 11296 | SUPPL | 2011-10-12 |
| 11295 | SUPPL | 2011-10-12 |
| 33575 | SUPPL | 2009-05-12 |
| 15119 | SUPPL | 2009-05-01 |
| 23543 | ORIG | 2008-02-01 |
| 15117 | SUPPL | 2006-10-23 |
| 33574 | SUPPL | 2006-10-18 |
| 15116 | SUPPL | 2006-01-20 |
| 33573 | SUPPL | 2006-01-13 |
| 15115 | SUPPL | 2004-06-02 |