Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076919
Company: MYLAN

• Other Important Information from FDA

Products on ANDA 076919

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	Prescription	AB	No	No
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076919

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/04/2008	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
02/10/2025	SUPPL-31	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/10/2025	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/10/2025	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/10/2025	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/10/2025	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/10/2025	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/10/2025	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/10/2025	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
02/10/2025	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
09/24/2014	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/24/2014	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/24/2014	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/24/2014	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/24/2014	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
11/02/2009	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 076919

LEVETIRACETAM

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KEPPRA	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	Yes	AB	021035	UCB INC
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	216375	ALKEM LABS LTD
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	078993	AUROBINDO PHARMA
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	201293	CHARTWELL RX
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	090515	HETERO LABS LTD III
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	079042	INGENUS PHARMS LLC
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	078154	LUPIN
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	214815	MSN
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	076919	MYLAN
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	078526	ORBION PHARMS
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	077319	OXFORD PHARMS
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	078106	PRINSTON INC
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	090767	RISING
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	215069	SCIEGEN PHARMS
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	076920	SENORES PHARMS
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	078858	TORRENT PHARMS
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	078869	VIWIT PHARM
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET;ORAL	Prescription	No	AB	091491	ZHEJIANG JINGXIN

TABLET;ORAL; 750MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KEPPRA	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	Yes	AB	021035	UCB INC
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	216375	ALKEM LABS LTD
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	078993	AUROBINDO PHARMA
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	201293	CHARTWELL RX
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	090515	HETERO LABS LTD III
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	079042	INGENUS PHARMS LLC
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	078154	LUPIN
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	214815	MSN
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	076919	MYLAN
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	078526	ORBION PHARMS
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	077319	OXFORD PHARMS
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	078106	PRINSTON INC
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	090767	RISING
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	215069	SCIEGEN PHARMS
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	076920	SENORES PHARMS
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	078858	TORRENT PHARMS
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	078869	VIWIT PHARM
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET;ORAL	Prescription	No	AB	091491	ZHEJIANG JINGXIN