Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021035
Company: UCB INC
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.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/12/2024 | SUPPL-115 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021035s115,021505s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021035Orig1s115, 021505Orig1s053, 021872Orig1s035, 022285Orig1s036ltr.pdf | |
| 08/31/2023 | SUPPL-113 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021035s113,021505s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021505Orig1s052,021035Orig1s113ltr.pdf | |
| 08/17/2023 | SUPPL-112 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021035s112,021505s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021505Orig1s051;021035Orig1s112;021872Orig1s034;022285Orig1s034ltr.pdf | |
| 09/30/2020 | SUPPL-104 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021035s104,021505s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021035Orig1s104, 021505Orig1s044, 022285Orig1s029, 021872Orig1s029ltr.pdf | |
| 10/23/2019 | SUPPL-102 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021035s102,021505s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021035Orig1s102, 021505Orig1s042, 021872Orig1s028, 022285Orig1s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021035Orig1s102.pdf | |
| 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-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
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 | REMS-Proposal, 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 | |
| 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 |
|---|---|---|---|---|---|
| 03/12/2024 | SUPPL-115 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021035s115,021505s053lbl.pdf | |
| 08/31/2023 | SUPPL-113 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021035s113,021505s052lbl.pdf | |
| 08/17/2023 | SUPPL-112 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021035s112,021505s051lbl.pdf | |
| 09/30/2020 | SUPPL-104 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021035s104,021505s044lbl.pdf | |
| 10/23/2019 | SUPPL-102 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021035s102,021505s042lbl.pdf | |
| 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-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.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 | |
| 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 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.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-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 | 216375 | ALKEM LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078993 | AUROBINDO PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 201293 | CHARTWELL RX |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 090515 | HETERO LABS LTD III |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 079042 | INGENUS PHARMS LLC |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078154 | LUPIN |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 214815 | MSN |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078526 | ORBION PHARMS |
| 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 | 090767 | RISING |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 215069 | SCIEGEN PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 076920 | SENORES PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078858 | TORRENT PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078869 | VIWIT PHARM |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 091491 | ZHEJIANG JINGXIN |
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Prescription | No | AB | 078918 | ZYDUS PHARMS USA INC |
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 | 216375 | ALKEM LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078993 | AUROBINDO PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 201293 | CHARTWELL RX |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 090515 | HETERO LABS LTD III |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 079042 | INGENUS PHARMS LLC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078154 | LUPIN |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 214815 | MSN |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 076919 | MYLAN |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078526 | ORBION PHARMS |
| 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 | 090767 | RISING |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 215069 | SCIEGEN PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 076920 | SENORES PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078858 | TORRENT PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 078869 | VIWIT PHARM |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Prescription | No | AB | 091491 | ZHEJIANG JINGXIN |
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 | 216375 | ALKEM LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078993 | AUROBINDO PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 201293 | CHARTWELL RX |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 090515 | HETERO LABS LTD III |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 079042 | INGENUS PHARMS LLC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078154 | LUPIN |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 214815 | MSN |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 076919 | MYLAN |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078526 | ORBION PHARMS |
| 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 | 090767 | RISING |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 215069 | SCIEGEN PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 076920 | SENORES PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078858 | TORRENT PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 078869 | VIWIT PHARM |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Prescription | No | AB | 091491 | ZHEJIANG JINGXIN |
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 | 216375 | ALKEM LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078993 | AUROBINDO PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 201293 | CHARTWELL RX |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 090515 | HETERO LABS LTD III |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 079042 | INGENUS PHARMS LLC |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 090025 | LUPIN |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 214815 | MSN |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 090261 | MYLAN |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 090484 | ORBION PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078106 | PRINSTON INC |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 090767 | RISING |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 215069 | SCIEGEN PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078904 | SENORES PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078858 | TORRENT PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078869 | VIWIT PHARM |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 091491 | ZHEJIANG JINGXIN |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;ORAL | Prescription | No | AB | 078918 | ZYDUS PHARMS USA INC |