Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090893
Company: LUPIN LTD

Products on ANDA 090893

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 090893

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/2011	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
11/22/2024	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/24/2023	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
03/16/2023	SUPPL-20	Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
03/16/2023	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/16/2023	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
03/16/2023	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/16/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/24/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/24/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
11/03/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/12/2013	SUPPL-3	REMS-Modified, Labeling		Label is not available on this site.
11/03/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.