Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022285
Company: UCB INC
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 |
|---|---|---|---|---|---|
| 03/12/2024 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022285s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021035Orig1s115, 021505Orig1s053, 021872Orig1s035, 022285Orig1s036ltr.pdf | |
| 08/17/2023 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022285s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021505Orig1s051;021035Orig1s112;021872Orig1s034;022285Orig1s034ltr.pdf | |
| 09/30/2020 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022285s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021035Orig1s104, 021505Orig1s044, 022285Orig1s029, 021872Orig1s029ltr.pdf | |
| 10/23/2019 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022285s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021035Orig1s102, 021505Orig1s042, 021872Orig1s028, 022285Orig1s028ltr.pdf | |
| 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-Medication Guide, Labeling-Package Insert, 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 | Labeling, REMS-Proposal |
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 |
|---|---|---|---|---|---|
| 03/12/2024 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022285s036lbl.pdf | |
| 08/17/2023 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022285s034lbl.pdf | |
| 09/30/2020 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022285s029lbl.pdf | |
| 10/23/2019 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022285s028lbl.pdf | |
| 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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022285s017lbl.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-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 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s002s007lbl.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-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 | 091093 | ACTAVIS LABS FL INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204754 | AIPING PHARM INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204511 | ANDA REPOSITORY |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091261 | APOTEX INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207175 | HISUN PHARM HANGZHOU |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091399 | LUPIN LTD |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212688 | OVERSEAS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201464 | PHARMADAX 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 | 205130 | SCIEGEN PHARMS INC |
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 | 091093 | ACTAVIS LABS FL INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204754 | AIPING PHARM INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204511 | ANDA REPOSITORY |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091261 | APOTEX INC |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207175 | HISUN PHARM HANGZHOU |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091399 | LUPIN LTD |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212688 | OVERSEAS |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201464 | PHARMADAX 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 | 205130 | SCIEGEN PHARMS INC |