Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021014
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 078005 ANI PHARMS INC
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 077747 APOTEX INC
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 077794 SUN PHARM INDS
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 077801 TARO
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 077795 WEST-WARD PHARMS INT
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 078005 ANI PHARMS INC
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 077747 APOTEX INC
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 077794 SUN PHARM INDS
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 077801 TARO
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 077795 WEST-WARD PHARMS INT
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 078005 ANI PHARMS INC
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 077747 APOTEX INC
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 077794 SUN PHARM INDS
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 077801 TARO
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 077795 WEST-WARD PHARMS INT
TRILEPTAL OXCARBAZEPINE 600MG TABLET;ORAL Prescription Yes AB 021014 NOVARTIS

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