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 |
| 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-Medication Guide | 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-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 |