Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021872
Company: UCB INC
Company: UCB INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KEPPRA | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021872lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021872s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/12/2024 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021872s035lbl.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/2023/021872s034lbl.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/2020/021872s029lbl.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/2019/021872s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021035Orig1s102, 021505Orig1s042, 021872Orig1s028, 022285Orig1s028ltr.pdf | |
| 10/24/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021872s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s100,021505Orig1s040,021872Orig1s024,022285Orig1s026ltr.pdf | |
| 04/24/2017 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021872s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021035Orig1s099,021505Orig1s038,021872Orig1s023,022285Orig1s025ltr.pdf | |
| 10/26/2016 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021872s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022285Orig1s023,021035Orig1s096,021505Orig1s036,021872Orig1s022ltr.pdf | |
| 04/06/2016 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021872s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021872Orig1s021ltr.pdf | |
| 08/14/2015 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/2014 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s094,021505Orig1s034,021872Orig1s018,022285Orig1s020ltr.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/2015/021872s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf | |
| 10/30/2014 | SUPPL-16 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021872Orig1s016ltr.pdf | |
| 03/07/2014 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021035Orig1s091,021505Orig1s031,021872Orig1s015,022285Orig1s016,s019ltr.pdf | |
| 07/25/2013 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf | |
| 07/25/2013 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf | |
| 05/16/2008 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021872s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021872s005ltr.pdf | |
| 09/12/2007 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf | |
| 09/12/2007 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021872s002,021872s003,021035s062,021505s015ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/12/2024 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021872s035lbl.pdf | |
| 08/17/2023 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021872s034lbl.pdf | |
| 09/30/2020 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021872s029lbl.pdf | |
| 10/23/2019 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021872s028lbl.pdf | |
| 10/24/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021872s024lbl.pdf | |
| 04/24/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021872s023lbl.pdf | |
| 10/26/2016 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021872s022lbl.pdf | |
| 04/06/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021872s021lbl.pdf | |
| 03/10/2015 | SUPPL-17 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021872s017lbl.pdf | |
| 03/10/2015 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021872s017lbl.pdf | |
| 03/10/2015 | SUPPL-17 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021872s017lbl.pdf | |
| 10/30/2014 | SUPPL-16 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s016lbl.pdf | |
| 08/07/2014 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s018lbl.pdf | |
| 03/07/2014 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021872s015lbl.pdf | |
| 07/25/2013 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf | |
| 07/25/2013 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021872s012s013lbl.pdf | |
| 05/16/2008 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021872s005lbl.pdf | |
| 09/12/2007 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf | |
| 09/12/2007 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021872s002s003lbl.pdf | |
| 07/31/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021872lbl.pdf |
KEPPRA
INJECTABLE;INTRAVENOUS; 500MG/5ML (100MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KEPPRA | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 021872 | UCB INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091485 | ADRASTEA PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204312 | EUGIA PHARMA |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090876 | FRESENIUS KABI USA |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 209781 | HAINAN POLY PHARM |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090981 | HIKMA FARMACEUTICA |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202869 | HOSPIRA INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211954 | MICRO LABS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215980 | MSN |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203308 | MYLAN LABS LTD |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 209474 | PRINSTON INC |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091627 | SAGENT PHARMS |
| LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090754 | SUN PHARM INDS LTD |