Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202958
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVETIRACETAM LEVETIRACETAM 1GM TABLET, EXTENDED RELEASE;ORAL Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/25/2015 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202958Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202958Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/10/2020 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/10/2020 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/10/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/10/2020 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/10/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

09/10/2020 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/25/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202958Orig1s000lbl.pdf

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