Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091557
Company: ACTAVIS ELIZABETH

Products on ANDA 091557

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091557

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2011	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2024	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/27/2024	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/10/2021	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/10/2021	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/10/2021	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
04/07/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/07/2016	SUPPL-7	Labeling-Package Insert		Label is not available on this site.