Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021035
Company: UCB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KEPPRA LEVETIRACETAM 250MG TABLET;ORAL Prescription AB Yes No
KEPPRA LEVETIRACETAM 500MG TABLET;ORAL Prescription AB Yes No
KEPPRA LEVETIRACETAM 750MG TABLET;ORAL Prescription AB Yes No
KEPPRA LEVETIRACETAM 1GM TABLET;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
11/30/1999 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21035_Keppra.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2017 SUPPL-100 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s100,021505s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s100,021505Orig1s040,021872Orig1s024,022285Orig1s026ltr.pdf
04/24/2017 SUPPL-99 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s099,021505s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s099,021505Orig1s038,021872Orig1s023,022285Orig1s025ltr.pdf
10/26/2016 SUPPL-96 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021035s096,021505s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s023,021035Orig1s096,021505Orig1s036,021872Orig1s022ltr.pdf
02/04/2016 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

08/07/2014 SUPPL-94 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021035s094,021505s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505Orig1s034,021872Orig1s018,022285Orig1s020ltr.pdf
03/10/2015 SUPPL-93 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf
11/13/2012 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

03/07/2014 SUPPL-91 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021035s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf
08/10/2011 SUPPL-90 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-89 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021035s089,021505s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf
12/16/2011 SUPPL-85 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf
12/16/2011 SUPPL-83 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf
04/23/2009 SUPPL-80 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021035s078,s080.021505s021,s024ltr.pdf
04/23/2009 SUPPL-79 Labeling

Label is not available on this site.

04/23/2009 SUPPL-78 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021035s078,s080.021505s021,s024ltr.pdf
12/16/2011 SUPPL-74 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf
12/16/2011 SUPPL-73 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf
09/12/2007 SUPPL-62 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf
03/19/2007 SUPPL-57 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021035s057,021505s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021035s057, 021505s013ltr.pdf
08/16/2006 SUPPL-55 Labeling-Container/Carton Labels

Label is not available on this site.

08/15/2006 SUPPL-54 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021035s050s054,021505s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s050, 054, 21505s009LTR.pdf
12/16/2011 SUPPL-52 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s052,s073,s074,s083,s085,021505s019,s020,s025,s026ltr.pdf
08/15/2006 SUPPL-50 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021035s050s054,021505s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s050, 054, 21505s009LTR.pdf
01/06/2006 SUPPL-48 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021035s048ltr.pdf
06/21/2005 SUPPL-40 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021035s040,021505s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021035s040,021505s007ltr.pdf
01/24/2006 SUPPL-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021505s006_021035s038ltr.pdf
10/26/2004 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s033,21505s003ltr.pdf
10/26/2004 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s032,21505s002ltr.pdf
09/03/2003 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21035slr030lr.pdf
10/17/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/2002 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/2002 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21035slr013ltr.pdf
05/07/2002 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/04/2002 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/04/2002 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/24/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/22/2002 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21035slr013ltr.pdf
11/27/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/26/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/05/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/09/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/27/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/15/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/10/2000 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/24/2017 SUPPL-100 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s100,021505s040lbl.pdf
04/24/2017 SUPPL-99 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s099,021505s038lbl.pdf
10/26/2016 SUPPL-96 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021035s096,021505s036lbl.pdf
03/10/2015 SUPPL-93 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf
03/10/2015 SUPPL-93 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf
03/10/2015 SUPPL-93 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf
08/07/2014 SUPPL-94 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021035s094,021505s034lbl.pdf
03/07/2014 SUPPL-91 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021035s091lbl.pdf
07/25/2013 SUPPL-89 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021035s089,021505s030lbl.pdf
12/16/2011 SUPPL-85 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf
12/16/2011 SUPPL-83 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf
12/16/2011 SUPPL-74 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf
12/16/2011 SUPPL-73 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf
12/16/2011 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf
04/23/2009 SUPPL-80 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf
04/23/2009 SUPPL-80 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf
04/23/2009 SUPPL-78 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf
03/19/2007 SUPPL-57 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021035s057,021505s013lbl.pdf
08/15/2006 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021035s050s054,021505s009lbl.pdf
08/15/2006 SUPPL-50 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021035s050s054,021505s009lbl.pdf
06/21/2005 SUPPL-40 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021035s040,021505s007lbl.pdf
11/30/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21035lbl.pdf

KEPPRA

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KEPPRA LEVETIRACETAM 250MG TABLET;ORAL Prescription Yes AB 021035 UCB INC
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 090843 ACCORD HLTHCARE
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078042 ACI HEALTHCARE LTD
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 090767 ACIC PHARMS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078869 APOTEX INC
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078993 AUROBINDO PHARMA
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 090511 BRECKENRIDGE PHARM
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 201293 CHARTWELL RX
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 076920 DR REDDYS LABS LTD
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 090515 HETERO LABS LTD III
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078234 INVAGEN PHARMS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078154 LUPIN
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 076919 MYLAN
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078526 ORCHID HLTHCARE
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 077319 OXFORD PHARMS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078106 PRINSTON INC
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078960 TARO
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078101 TEVA PHARMS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078858 TORRENT PHARMS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 091491 VINTAGE PHARMS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 079042 WOCKHARDT
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 078918 ZYDUS PHARMS USA INC
ROWEEPRA LEVETIRACETAM 250MG TABLET;ORAL Prescription No AB 090906 LOTUS PHARM CO LTD

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KEPPRA LEVETIRACETAM 500MG TABLET;ORAL Prescription Yes AB 021035 UCB INC
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 090843 ACCORD HLTHCARE
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078042 ACI HEALTHCARE LTD
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 090767 ACIC PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078869 APOTEX INC
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078993 AUROBINDO PHARMA
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 090511 BRECKENRIDGE PHARM
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 201293 CHARTWELL RX
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 076920 DR REDDYS LABS LTD
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 090515 HETERO LABS LTD III
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078234 INVAGEN PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078154 LUPIN
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 076919 MYLAN
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078526 ORCHID HLTHCARE
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 077319 OXFORD PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078106 PRINSTON INC
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 205102 SECAN PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078960 TARO
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078101 TEVA PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 078858 TORRENT PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 091491 VINTAGE PHARMS
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 079042 WOCKHARDT
ROWEEPRA LEVETIRACETAM 500MG TABLET;ORAL Prescription No AB 090906 LOTUS PHARM CO LTD

TABLET;ORAL; 750MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KEPPRA LEVETIRACETAM 750MG TABLET;ORAL Prescription Yes AB 021035 UCB INC
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 090843 ACCORD HLTHCARE
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078042 ACI HEALTHCARE LTD
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 090767 ACIC PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078869 APOTEX INC
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078993 AUROBINDO PHARMA
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 090511 BRECKENRIDGE PHARM
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 201293 CHARTWELL RX
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 076920 DR REDDYS LABS LTD
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 090515 HETERO LABS LTD III
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078234 INVAGEN PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078154 LUPIN
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 076919 MYLAN
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078526 ORCHID HLTHCARE
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 077319 OXFORD PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078106 PRINSTON INC
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078960 TARO
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078101 TEVA PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 078858 TORRENT PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 091491 VINTAGE PHARMS
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 079042 WOCKHARDT
ROWEEPRA LEVETIRACETAM 750MG TABLET;ORAL Prescription No AB 090906 LOTUS PHARM CO LTD

TABLET;ORAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KEPPRA LEVETIRACETAM 1GM TABLET;ORAL Prescription Yes AB 021035 UCB INC
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 090843 ACCORD HLTHCARE
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 078042 ACI HEALTHCARE LTD
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 090767 ACIC PHARMS
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 078869 APOTEX INC
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 078993 AUROBINDO PHARMA
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 090511 BRECKENRIDGE PHARM
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 201293 CHARTWELL RX
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 078904 DR REDDYS LABS LTD
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 090515 HETERO LABS LTD III
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 090025 LUPIN
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 090261 MYLAN
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 090484 ORCHID HLTHCARE
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 078106 PRINSTON INC
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 205102 SECAN PHARMS
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 078960 TARO
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 078101 TEVA PHARMS
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 078858 TORRENT PHARMS
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 091491 VINTAGE PHARMS
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 079042 WOCKHARDT
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 078918 ZYDUS PHARMS USA INC
ROWEEPRA LEVETIRACETAM 1GM TABLET;ORAL Prescription No AB 090906 LOTUS PHARM CO LTD

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