Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021285
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRILEPTAL OXCARBAZEPINE 300MG/5ML SUSPENSION;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
05/25/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21285lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-285_Trileptal_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-285_Trileptal.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2019 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021285s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021014Orig1s043,021285Orig1s036Ltr.pdf
03/22/2018 SUPPL-35 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-34 Labeling-Package Insert Label (PDF)
Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021014Orig1ss041,021285Orig1s034ltr.pdf
03/23/2017 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021285s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021014Orig1s036,021285Orig1s031ltr.pdf
06/06/2014 SUPPL-30 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-29 Manufacturing (CMC)

Label is not available on this site.

02/28/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/03/2014 SUPPL-27 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-25 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-23 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-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
04/23/2009 SUPPL-21 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-20 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
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-18 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
08/31/2007 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021014s021, 021285s014ltr.pdf
03/03/2011 SUPPL-13 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-9 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
10/28/2005 SUPPL-8 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-7 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
09/10/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/2002 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21014s006ltr.pdf
01/18/2002 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-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021285s036lbl.pdf
03/22/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf
11/17/2017 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021014s041,021285s034lbl.pdf
03/23/2017 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021285s031lbl.pdf
07/03/2014 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s033,021285s027lbl.pdf
06/06/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s035,021285s030lbl.pdf
02/08/2013 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021014s029,021285s023lbl.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-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf
03/03/2011 SUPPL-20 REMS-Proposal 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-18 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
03/03/2011 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf
03/03/2011 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf
04/23/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021014s026,021285s021lbl.pdf
10/28/2005 SUPPL-8 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021014s013lbl.pdf
03/25/2005 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21014s012,21285s007lbl.pdf
05/25/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21285lbl.pdf

TRILEPTAL

SUSPENSION;ORAL; 300MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 202961 AMNEAL PHARMS
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 078734 SUN PHARM INDS LTD
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 201193 WEST-WARD PHARMS INT
TRILEPTAL OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription Yes AB 021285 NOVARTIS

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