Drugs@FDA: FDA-Approved Drugs

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

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