Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090511
Company: NOSTRUM LABS INC

Products on ANDA 090511

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET;ORAL	Discontinued	None	No	No
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Discontinued	None	No	No
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Discontinued	None	No	No
LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090511

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/2011	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
09/17/2012	SUPPL-1	Labeling-Medication Guide		Label is not available on this site.