Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079063
Company: AUROBINDO PHARMA

Products on ANDA 079063

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079063

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/2009/079063s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2024	SUPPL-32	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/28/2024	SUPPL-30	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/28/2024	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/28/2024	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/28/2024	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
08/14/2017	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/28/2024	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/28/2024	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/28/2024	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
11/03/2014	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/03/2014	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
11/03/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/27/2013	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/26/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/13/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
06/30/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 079063

LEVETIRACETAM

SOLUTION;ORAL; 100MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KEPPRA	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	Yes	AA	021505	UCB INC
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	078976	ACTAVIS MID ATLANTIC
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	090461	AJENAT PHARMS
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	203067	ALEMBIC
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	090992	AMNEAL PHARMS
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	218080	ANDA REPOSITORY
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	079063	AUROBINDO PHARMA
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	079120	BIONPHARMA
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	090263	CHARTWELL MOLECULAR
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	203052	HETERO LABS LTD III
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	214757	MSN
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	201157	PHARM ASSOC
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	090079	QUAGEN
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	078582	STRIDES PHARMA
LEVETIRACETAM	LEVETIRACETAM	100MG/ML	SOLUTION;ORAL	Prescription	No	AA	078774	TARO