Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203059
Company: SUN PHARM

Products on ANDA 203059

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 203059

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/2013	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
11/16/2023	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/16/2021	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/13/2020	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
08/13/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
08/13/2020	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/21/2020	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/21/2020	SUPPL-10	Labeling		Label is not available on this site.
06/14/2015	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/14/2015	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/14/2015	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.