Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022285
Company: UCB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KEPPRA XR LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
KEPPRA XR LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/12/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022285lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022285s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022285s000_TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022285s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2017 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022285s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s100,021505Orig1s040,021872Orig1s024,022285Orig1s026ltr.pdf
04/24/2017 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022285s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s099,021505Orig1s038,021872Orig1s023,022285Orig1s025ltr.pdf
10/26/2016 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022285s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s023,021035Orig1s096,021505Orig1s036,021872Orig1s022ltr.pdf
04/06/2016 SUPPL-22 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022285s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s022ltr.pdf
08/07/2014 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505Orig1s034,021872Orig1s018,022285Orig1s020ltr.pdf
03/07/2014 SUPPL-19 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s016s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf
08/01/2014 SUPPL-18 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022285Orig1s018ltr.pdf
03/10/2015 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022285s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf
03/07/2014 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s016s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf
07/25/2013 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022285s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf
08/10/2011 SUPPL-14 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s090,021505s029,022285s014ltr.pdf
07/25/2013 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022285s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf
04/23/2009 SUPPL-7 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s002s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022285s002,s007ltr.pdf
04/23/2009 SUPPL-3 Labeling

Label is not available on this site.

04/23/2009 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s002s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022285s002,s007ltr.pdf
02/12/2009 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022285s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/24/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022285s026lbl.pdf
04/24/2017 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022285s025lbl.pdf
10/26/2016 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022285s023lbl.pdf
04/06/2016 SUPPL-22 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022285s022lbl.pdf
03/10/2015 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022285s017lbl.pdf
03/10/2015 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022285s017lbl.pdf
03/10/2015 SUPPL-17 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022285s017lbl.pdf
08/07/2014 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s020lbl.pdf
08/01/2014 SUPPL-18 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s018lbl.pdf
03/07/2014 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s016s019lbl.pdf
03/07/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022285s016s019lbl.pdf
07/25/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022285s013s015lbl.pdf
07/25/2013 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022285s013s015lbl.pdf
04/23/2009 SUPPL-7 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s002s007lbl.pdf
04/23/2009 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s002s007lbl.pdf
04/23/2009 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s002s007lbl.pdf
02/12/2009 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s001lbl.pdf
02/12/2009 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s001lbl.pdf
09/12/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022285lbl.pdf

KEPPRA XR

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 203059 SUN PHARM
LEVETIRACETAM LEVETIRACETAM 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091285 SUN PHARM INDUSTRIES
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

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 203059 SUN PHARM
LEVETIRACETAM LEVETIRACETAM 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091285 SUN PHARM INDUSTRIES
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

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