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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204417
Company: TRIPOINT

Medication Guide

Products on NDA 204417

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELEPSIA XR	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ELEPSIA XR	LEVETIRACETAM	1.5GM	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204417

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204417s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/204417Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/12/2024	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204417s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204417Orig1s009ltr.pdf
12/17/2020	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204417s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204417Orig1s004ltr.pdf

Labels for NDA 204417

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/12/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204417s009lbl.pdf
12/17/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204417s004lbl.pdf
12/20/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204417s000lbl.pdf

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