Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021446
Company: UPJOHN
Company: UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LYRICA | PREGABALIN | 25MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 50MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 75MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 150MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 200MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 225MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| LYRICA | PREGABALIN | 300MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/13/2023 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021446s041,022488s018lbl.pdf | |
| 04/03/2020 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021446s040,%20022488s017lbl.pdf | |
| 05/23/2019 | SUPPL-36 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf | |
| 05/03/2018 | SUPPL-35 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf | |
| 12/22/2016 | SUPPL-32 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s032,022488s011lbl.pdf | |
| 03/09/2016 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf | |
| 12/23/2013 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021446s029,022488s008lbl.pdf | |
| 06/20/2012 | SUPPL-28 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021446s028lbl.pdf | |
| 08/24/2011 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022488-s004-0211446s025lbl.pdf | |
| 06/20/2011 | SUPPL-26 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s026,022488s005lbl.pdf | |
| 04/26/2011 | SUPPL-24 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf | |
| 04/26/2011 | SUPPL-24 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf | |
| 04/26/2011 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf | |
| 04/26/2011 | SUPPL-23 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf | |
| 04/26/2011 | SUPPL-23 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf | |
| 10/08/2010 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021446s021lbl.pdf | |
| 01/04/2010 | SUPPL-18 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf | |
| 01/04/2010 | SUPPL-18 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf | |
| 01/04/2010 | SUPPL-18 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf | |
| 04/23/2009 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf | |
| 04/23/2009 | SUPPL-14 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf | |
| 04/23/2009 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf | |
| 04/23/2009 | SUPPL-13 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf | |
| 06/21/2007 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021446s010lbl.pdf | |
| 02/17/2006 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021446s002,s003lbl.pdf | |
| 02/17/2006 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021446s002,s003lbl.pdf |