Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091261
Company: APOTEX INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/12/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091261s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/26/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/26/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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 091557 ACTAVIS ELIZABETH
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 091360 ANCHEN PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091261 APOTEX INC
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202167 DEXCEL PHARMA
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204754 ECI PHARMS LLC
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204511 INTELLIPHARMACEUTICS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202095 LOTUS PHARM CO LTD
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091399 LUPIN LTD
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201464 PHARMADAX INC
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207175 PHARMTAK 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 202524 ROUSES POINT PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091285 SUN PHARM INDS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203059 SUN PHARMA GLOBAL
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091430 TEVA PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091338 TORRENT PHARMS LTD
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091291 VIRTUS PHARMS

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 091557 ACTAVIS ELIZABETH
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 091360 ANCHEN PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091261 APOTEX INC
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202167 DEXCEL PHARMA
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204754 ECI PHARMS LLC
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204511 INTELLIPHARMACEUTICS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202095 LOTUS PHARM CO LTD
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091399 LUPIN LTD
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201464 PHARMADAX INC
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207175 PHARMTAK 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 202524 ROUSES POINT PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091285 SUN PHARM INDS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203059 SUN PHARMA GLOBAL
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091430 TEVA PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091338 TORRENT PHARMS LTD
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091291 VIRTUS PHARMS

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