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Drugs@FDA: FDA-Approved Drugs

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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	No
SPRITAM	LEVETIRACETAM	750MG	TABLET, FOR SUSPENSION;ORAL	Prescription	None	Yes	No
SPRITAM	LEVETIRACETAM	1GM	TABLET, FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes

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.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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
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
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

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