Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021505
Company: UCB INC
Company: UCB INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KEPPRA | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
07/15/2003 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21505ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/0221505_s000_Keppra.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/12/2024 | SUPPL-53 | 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-52 | 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-51 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021035s112,021505s051lbl.pdf | |
09/30/2020 | SUPPL-44 | 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-42 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (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 | |
10/24/2017 | SUPPL-40 | Labeling-Patient 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-38 | 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-36 | 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 | |
08/07/2014 | SUPPL-34 | 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-33 | Labeling-Medication Guide, Labeling-Package Insert, 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 | |
09/13/2013 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/07/2014 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021505s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf | |
07/25/2013 | SUPPL-30 | Labeling |
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 | |
08/10/2011 | SUPPL-29 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021035s090,021505s029,022285s014ltr.pdf |
12/16/2011 | SUPPL-26 | 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-25 | 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-24 | 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-22 | Labeling |
Label is not available on this site. |
||
04/23/2009 | SUPPL-21 | 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-20 | 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-19 | 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-15 | 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-13 | 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 | |
08/15/2006 | SUPPL-9 | 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 | |
06/21/2005 | SUPPL-7 | 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-6 | 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-3 | 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-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21035s032,21505s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/12/2024 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021035s115,021505s053lbl.pdf | |
08/31/2023 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021035s113,021505s052lbl.pdf | |
08/17/2023 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021035s112,021505s051lbl.pdf | |
09/30/2020 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021035s104,021505s044lbl.pdf | |
10/23/2019 | SUPPL-42 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021035s102,021505s042lbl.pdf | |
10/24/2017 | SUPPL-40 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s100,021505s040lbl.pdf | |
04/24/2017 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s099,021505s038lbl.pdf | |
10/26/2016 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021035s096,021505s036lbl.pdf | |
03/10/2015 | SUPPL-33 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf | |
03/10/2015 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf | |
03/10/2015 | SUPPL-33 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf | |
08/07/2014 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021035s094,021505s034lbl.pdf | |
03/07/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021505s031lbl.pdf | |
07/25/2013 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021035s089,021505s030lbl.pdf | |
12/16/2011 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf | |
12/16/2011 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf | |
12/16/2011 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf | |
12/16/2011 | SUPPL-19 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021035s052s073s074s083s085,021505s019s020s025s026lbl.pdf | |
04/23/2009 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf | |
04/23/2009 | SUPPL-24 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf | |
04/23/2009 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf | |
03/19/2007 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021035s057,021505s013lbl.pdf | |
08/15/2006 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021035s050s054,021505s009lbl.pdf | |
06/21/2005 | SUPPL-7 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021035s040,021505s007lbl.pdf |
KEPPRA
SOLUTION;ORAL; 100MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KEPPRA | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 021505 | UCB INC |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 078582 | ACI |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 078976 | ACTAVIS MID ATLANTIC |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 203067 | ALEMBIC |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090992 | AMNEAL PHARMS |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 079063 | AUROBINDO PHARMA |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090461 | BELCHER |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 079120 | BIONPHARMA |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090263 | CHARTWELL MOLECULAR |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 203052 | HETERO LABS LTD III |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090893 | LUPIN LTD |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 214757 | MSN |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 201157 | PHARM ASSOC |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090079 | QUAGEN |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 214673 | STRIDES PHARMA |
LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;ORAL | Prescription | No | AA | 078774 | TARO |