Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021014
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRILEPTAL | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | AB | Yes | No |
| TRILEPTAL | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | AB | Yes | No |
| TRILEPTAL | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/23/2025 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021014s049,021285s041lbl.pdf | |
| 09/23/2025 | SUPPL-49 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021014s049,021285s041lbl.pdf | |
| 09/04/2024 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021014s050lbl.pdf | |
| 01/04/2019 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021014s043lbl.pdf | |
| 03/22/2018 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf | |
| 11/17/2017 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021014s041,021285s034lbl.pdf | |
| 03/23/2017 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021014s036lbl.pdf | |
| 07/03/2014 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s033,021285s027lbl.pdf | |
| 06/06/2014 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s035,021285s030lbl.pdf | |
| 02/08/2013 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021014s029,021285s023lbl.pdf | |
| 03/03/2011 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf | |
| 03/03/2011 | SUPPL-27 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf | |
| 03/03/2011 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf | |
| 03/03/2011 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf | |
| 03/03/2011 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf | |
| 03/03/2011 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf | |
| 03/03/2011 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf | |
| 03/03/2011 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf | |
| 04/23/2009 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021014s026,021285s021lbl.pdf | |
| 10/28/2005 | SUPPL-13 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021014s013lbl.pdf | |
| 03/25/2005 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21014s012,21285s007lbl.pdf | |
| 08/07/2003 | SUPPL-3 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21014se5-003_trileptal_lbl.pdf | |
| 01/14/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21014lbl.pdf | |
| SUPPL-51 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021014Orig1s051lbl.pdf |