Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079107
Company: TOLMAR

Products on ANDA 079107

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079107

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/15/2009	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079107s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2014	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
11/03/2014	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
11/03/2014	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/26/2012	SUPPL-11	Labeling-Package Insert, REMS		Label is not available on this site.
11/03/2014	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/29/2010	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/20/2009	SUPPL-3	Labeling-Medication Guide, REMS-Proposal, Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.