Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202958
Company: APOTEX

Products on ANDA 202958

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202958

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
04/23/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
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-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 202958

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