An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 207958
Company: APRECIA PHARMS

Medication Guide

Products on NDA 207958

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPRITAM	LEVETIRACETAM	250MG	TABLET, FOR SUSPENSION;ORAL	Prescription	None	Yes	No
SPRITAM	LEVETIRACETAM	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes
SPRITAM	LEVETIRACETAM	750MG	TABLET, FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
SPRITAM	LEVETIRACETAM	1GM	TABLET, FOR SUSPENSION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207958

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2015	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207958s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207958Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207958Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2025	SUPPL-27	Efficacy-New Route Of Administration	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/207958s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207958Orig1s027ltr.pdf
03/12/2024	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207958s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207958Orig1s025ltr.pdf
06/14/2024	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207958s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207958Orig1s024ltr.pdf
08/31/2023	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207958s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207958Orig1s023ltr.pdf
01/19/2021	SUPPL-19	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207958s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207958Orig1s019ltr.pdf
09/12/2018	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207958s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207958Orig1s008Ltr.pdf
06/09/2017	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207958s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207958Orig1s004ltr.pdf
02/01/2016	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207958s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207958Orig1s002ltr.pdf
12/14/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 207958

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2025	SUPPL-27	Efficacy-New Route Of Administration	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/207958s027lbl.pdf
06/14/2024	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207958s024lbl.pdf
06/14/2024	SUPPL-24	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207958s024lbl.pdf
03/12/2024	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207958s025lbl.pdf
08/31/2023	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207958s023lbl.pdf
01/19/2021	SUPPL-19	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207958s019lbl.pdf
09/12/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207958s008lbl.pdf
09/12/2018	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207958s008lbl.pdf
06/09/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207958s004lbl.pdf
06/09/2017	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207958s004lbl.pdf
02/01/2016	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207958s002lbl.pdf
07/31/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207958s000lbl.pdf

Top