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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022416
Company: SUMITOMO PHARMA AM

Medication Guide

Summary Review

Products on NDA 022416

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APTIOM	ESLICARBAZEPINE ACETATE	200MG	TABLET;ORAL	Prescription	AB	Yes	No
APTIOM	ESLICARBAZEPINE ACETATE	400MG	TABLET;ORAL	Prescription	AB	Yes	No
APTIOM	ESLICARBAZEPINE ACETATE	600MG	TABLET;ORAL	Prescription	AB	Yes	No
APTIOM	ESLICARBAZEPINE ACETATE	800MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022416

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/08/2013	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022416s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022416Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022416Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022416Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/20/2024	SUPPL-21	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022416Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022416Orig1s021ltr.pdf
03/15/2019	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022416s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022416Orig1s011ltr.pdf
09/13/2017	SUPPL-9	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022416s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022416Orig1s009ltr.pdf
03/07/2017	SUPPL-6	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022416Orig1s006ltr.pdf
01/06/2016	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/10/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/11/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/27/2015	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022416s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022416Orig1s001ltr.pdf

Labels for NDA 022416

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/20/2024	SUPPL-21	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022416Orig1s021lbl.pdf
03/15/2019	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022416s011lbl.pdf
09/13/2017	SUPPL-9	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022416s009lbl.pdf
08/27/2015	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022416s001lbl.pdf
11/08/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022416s000lbl.pdf

Therapeutic Equivalents for NDA 022416

APTIOM

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APTIOM	ESLICARBAZEPINE ACETATE	200MG	TABLET;ORAL	Prescription	Yes	AB	022416	SUMITOMO PHARMA AM
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	200MG	TABLET;ORAL	Prescription	No	AB	211199	ALKEM LABS LTD
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	200MG	TABLET;ORAL	Prescription	No	AB	211238	DR REDDYS
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	200MG	TABLET;ORAL	Prescription	No	AB	211186	HETERO LABS LTD V

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APTIOM	ESLICARBAZEPINE ACETATE	400MG	TABLET;ORAL	Prescription	Yes	AB	022416	SUMITOMO PHARMA AM
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	400MG	TABLET;ORAL	Prescription	No	AB	211199	ALKEM LABS LTD
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	400MG	TABLET;ORAL	Prescription	No	AB	211238	DR REDDYS
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	400MG	TABLET;ORAL	Prescription	No	AB	211186	HETERO LABS LTD V

TABLET;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APTIOM	ESLICARBAZEPINE ACETATE	600MG	TABLET;ORAL	Prescription	Yes	AB	022416	SUMITOMO PHARMA AM
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	600MG	TABLET;ORAL	Prescription	No	AB	211199	ALKEM LABS LTD
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	600MG	TABLET;ORAL	Prescription	No	AB	211238	DR REDDYS
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	600MG	TABLET;ORAL	Prescription	No	AB	211186	HETERO LABS LTD V

TABLET;ORAL; 800MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APTIOM	ESLICARBAZEPINE ACETATE	800MG	TABLET;ORAL	Prescription	Yes	AB	022416	SUMITOMO PHARMA AM
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	800MG	TABLET;ORAL	Prescription	No	AB	211199	ALKEM LABS LTD
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	800MG	TABLET;ORAL	Prescription	No	AB	211238	DR REDDYS
ESLICARBAZEPINE ACETATE	ESLICARBAZEPINE ACETATE	800MG	TABLET;ORAL	Prescription	No	AB	211186	HETERO LABS LTD V

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