Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207175
Company: HISUN PHARM HANGZHOU

Products on ANDA 207175

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 207175

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2024	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/23/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/05/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/05/2021	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/05/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207175

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	203468	PRINSTON INC
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205130	SCIEGEN PHARMS
LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091338	TORRENT PHARMS LTD

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	203468	PRINSTON INC
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205130	SCIEGEN PHARMS
LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091338	TORRENT PHARMS LTD