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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202834
Company: CATALYST PHARMS

Medication Guide

Products on NDA 202834

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FYCOMPA	PERAMPANEL	2MG	TABLET;ORAL	Prescription	None	Yes	No
FYCOMPA	PERAMPANEL	4MG	TABLET;ORAL	Prescription	None	Yes	No
FYCOMPA	PERAMPANEL	6MG	TABLET;ORAL	Prescription	None	Yes	No
FYCOMPA	PERAMPANEL	8MG	TABLET;ORAL	Prescription	None	Yes	No
FYCOMPA	PERAMPANEL	10MG	TABLET;ORAL	Prescription	None	Yes	No
FYCOMPA	PERAMPANEL	12MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202834

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/22/2012	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202834lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202834Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202834Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2023	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202834Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202834Orig1s019ltr.pdf
10/26/2023	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202834Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202834Orig1s018ltr.pdf
05/30/2019	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202834s016,208277s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202834Orig1s016, 208277Orig1s004ltr.pdf
09/27/2018	SUPPL-14	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202834Orig1s014,208277Orig1s002ltr.pdf
07/26/2017	SUPPL-12	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202834Orig1s012,208277Orig1s001ltr.pdf
11/03/2016	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202834s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202834Orig1s011ltr.pdf
10/26/2016	SUPPL-10	Labeling		Label is not available on this site.
12/23/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/03/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/14/2015	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/14/2014	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s006ltr.pdf
06/19/2015	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202834s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202834Orig1s005ltr.pdf
02/14/2014	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s004ltr.pdf
02/24/2014	SUPPL-3	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s003ltr.pdf
09/02/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/30/2013	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202834s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202834Orig1s001ltr.pdf

Labels for NDA 202834

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2023	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202834Orig1s019lbl.pdf
10/26/2023	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202834Orig1s018lbl.pdf
05/30/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202834s016,208277s004lbl.pdf
09/27/2018	SUPPL-14	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf
07/26/2017	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf
11/03/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202834s011lbl.pdf
06/19/2015	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202834s005lbl.pdf
11/14/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s006lbl.pdf
02/14/2014	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s004lbl.pdf
02/14/2014	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s004lbl.pdf
06/30/2013	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202834s001lbl.pdf
10/22/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202834lbl.pdf

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