Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203468
Company: PRINSTON INC

Products on ANDA 203468

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203468

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/2015	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
11/16/2021	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/17/2021	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/16/2021	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
11/16/2021	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/16/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/16/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203468

LEVETIRACETAM

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KEPPRA XR	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022285	UCB INC
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091093	ACTAVIS LABS FL INC
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204754	AIPING PHARM INC
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204511	ANDA REPOSITORY
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091261	APOTEX INC
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207175	HISUN PHARM HANGZHOU
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091399	LUPIN LTD
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212688	OVERSEAS
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201464	PHARMADAX INC
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202533	PRINSTON INC
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203468	PRINSTON INC
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205130	SCIEGEN PHARMS INC

TABLET, EXTENDED RELEASE;ORAL; 750MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KEPPRA XR	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022285	UCB INC
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091093	ACTAVIS LABS FL INC
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204754	AIPING PHARM INC
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204511	ANDA REPOSITORY
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091261	APOTEX INC
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207175	HISUN PHARM HANGZHOU
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091399	LUPIN LTD
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212688	OVERSEAS
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201464	PHARMADAX INC
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202533	PRINSTON INC
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203468	PRINSTON INC
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205130	SCIEGEN PHARMS INC