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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/14/2000 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-014_Trileptal.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/04/2019 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021014s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021014Orig1s043,021285Orig1s036Ltr.pdf | |
| 03/22/2018 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021014Orig1s042,021285Orig1s035ltr.pdf | |
| 11/17/2017 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021014s041,021285s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021014Orig1ss041,021285Orig1s034ltr.pdf | |
| 05/06/2016 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/2016 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/2015 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/2017 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021014s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021014Orig1s036,021285Orig1s031ltr.pdf | |
| 06/06/2014 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s035,021285s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021014Orig1s035,021285Orig1s030ltr.pdf | |
| 05/08/2014 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2014 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s033,021285s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021014Orig1s033,021285Orig1s027ltr.pdf | |
| 10/30/2011 | SUPPL-31 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s031,021285s025ltr.pdf |
| 02/08/2013 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021014s029,021285s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021014Orig1s029,021285Orig1s023ltr.pdf | |
| 03/03/2011 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf | |
| 03/03/2011 | SUPPL-27 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf | |
| 04/23/2009 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021014s026,021285s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021014s026,021285s021ltr.pdf | |
| 03/03/2011 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf | |
| 03/03/2011 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf | |
| 03/03/2011 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf | |
| 08/31/2007 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021014s021, 021285s014ltr.pdf |
| 01/09/2007 | SUPPL-20 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/03/2011 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf | |
| 03/03/2011 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf | |
| 11/09/2005 | SUPPL-14 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021014s014ltr.pdf |
| 10/28/2005 | SUPPL-13 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021014s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021014s013,021285s008rel2_ltr.pdf | |
| 03/25/2005 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21014s012,21285s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21014s012,21285s007ltr.pdf | |
| 03/27/2003 | SUPPL-7 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21014scs007ltr.pdf |
| 04/01/2002 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21014s006ltr.pdf |
| 05/01/2002 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/14/2001 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/2003 | SUPPL-3 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21014se5-003_trileptal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21014se5-003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021014_s003_TrileptalTOC.cfm | |
| 08/29/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/02/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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 | 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-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 |
TRILEPTAL
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 215939 | ANNORA PHARMA |
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 078069 | BRECKENRIDGE PHARM |
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077802 | GLENMARK PHARMS LTD |
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077747 | RUBICON |
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 207717 | RUBICON |
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077794 | SUN PHARM INDS |
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077801 | TARO |
| TRILEPTAL | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | Yes | AB | 021014 | NOVARTIS |
TABLET;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 215939 | ANNORA PHARMA |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 078069 | BRECKENRIDGE PHARM |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077802 | GLENMARK PHARMS LTD |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077747 | RUBICON |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 207717 | RUBICON |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077794 | SUN PHARM INDS |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077801 | TARO |
| TRILEPTAL | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | Yes | AB | 021014 | NOVARTIS |
TABLET;ORAL; 600MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 215939 | ANNORA PHARMA |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 078069 | BRECKENRIDGE PHARM |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 077802 | GLENMARK PHARMS LTD |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 077747 | RUBICON |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 207717 | RUBICON |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 077794 | SUN PHARM INDS |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 077801 | TARO |
| TRILEPTAL | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | Yes | AB | 021014 | NOVARTIS |