Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091338
Company: TORRENT PHARMS LTD

Products on ANDA 091338

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 091338

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2012	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/091338Orig1s000OtherActionLtrs.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2021	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2020	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/18/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/13/2015	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/13/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/04/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/04/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091338

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