Application 021285
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRILEPTAL | OXCARBAZEPINE | SUSPENSION;ORAL | 300MG/5ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0357 | Trileptal | oxcarbazepine | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0781-6270 | Oxcarbazepine | oxcarbazepine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-6270 | Oxcarbazepine | oxcarbazepine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-6270 | Oxcarbazepine | oxcarbazepine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83529 | SUPPL | 2025-09-26 |
| 83528 | SUPPL | 2025-09-26 |
| 83436 | SUPPL | 2025-09-25 |
| 79544 | SUPPL | 2024-09-05 |
| 79542 | SUPPL | 2024-09-05 |
| 57416 | SUPPL | 2019-02-04 |
| 57137 | SUPPL | 2019-01-08 |
| 53500 | SUPPL | 2018-03-28 |
| 53247 | SUPPL | 2018-03-23 |
| 53246 | SUPPL | 2018-03-23 |
| 50491 | SUPPL | 2017-11-27 |
| 50490 | SUPPL | 2017-11-27 |
| 50461 | SUPPL | 2017-11-20 |
| 47727 | SUPPL | 2017-03-28 |
| 47667 | SUPPL | 2017-03-24 |
| 14885 | SUPPL | 2014-07-08 |
| 4916 | SUPPL | 2014-07-08 |
| 36582 | SUPPL | 2014-06-10 |
| 4917 | SUPPL | 2014-06-10 |
| 36581 | SUPPL | 2013-02-12 |
| 27376 | SUPPL | 2013-02-12 |
| 4915 | SUPPL | 2011-11-14 |
| 36580 | SUPPL | 2011-03-21 |
| 36579 | SUPPL | 2011-03-21 |
| 36578 | SUPPL | 2011-03-21 |
| 14884 | SUPPL | 2011-03-21 |
| 14882 | SUPPL | 2011-03-21 |
| 14881 | SUPPL | 2011-03-21 |
| 14880 | SUPPL | 2011-03-21 |
| 27375 | SUPPL | 2011-03-08 |
| 27374 | SUPPL | 2011-03-08 |
| 27373 | SUPPL | 2011-03-08 |
| 27372 | SUPPL | 2011-03-08 |
| 4913 | SUPPL | 2011-03-08 |
| 4912 | SUPPL | 2011-03-08 |
| 4910 | SUPPL | 2011-03-08 |
| 14883 | SUPPL | 2009-05-12 |
| 4914 | SUPPL | 2009-05-04 |
| 4911 | SUPPL | 2007-09-06 |
| 44609 | ORIG | 2007-03-16 |
| 4909 | SUPPL | 2005-11-01 |
| 36577 | SUPPL | 2005-10-28 |
| 36576 | SUPPL | 2005-03-30 |
| 27371 | SUPPL | 2005-03-30 |
| 42081 | ORIG | 2002-04-30 |
| 4908 | SUPPL | 2002-04-01 |
| 27370 | ORIG | 2001-05-29 |
| 14879 | ORIG | 2001-05-29 |