Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020427
Company: LUNDBECK PHARMS LLC
Company: LUNDBECK PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SABRIL | VIGABATRIN | 500MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/21/2009 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020427s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020427s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020427s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/12/2022 | SUPPL-26 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020427Orig1s026;022006Orig1s027ltr.pdf |
| 10/20/2021 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020427s025,022006s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020427Orig1s025,022006Orig1s026ltr.pdf | |
| 10/02/2020 | SUPPL-24 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020427Orig1s024,022006Orig1s025ltr.pdf |
| 10/20/2020 | SUPPL-23 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020427Orig1s023ltr.pdf |
| 09/12/2019 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022006Orig1s024,020427Orig1s022ltr.pdf |
| 01/24/2020 | SUPPL-21 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020427s021,022006s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020427Orig1s021, 022006Orig1s023ltr.pdf | |
| 07/31/2019 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020427s020,022006s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020427Orig1s020, 022006Orig1s022ltr.pdf | |
| 05/31/2019 | SUPPL-19 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020427Orig1s019, 022006Orig1s021ltr.pdf |
| 08/21/2018 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020427Orig1s018,022006Orig1s020ltr.pdf | |
| 10/23/2017 | SUPPL-17 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020427Orig1s017,022006Orig1s019ltr.pdf |
| 04/27/2017 | SUPPL-16 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020427s016,022006s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020427Orig1s016,022006Orig1s018ltr.pdf | |
| 09/18/2015 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020427s015,022006s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020427Orig1s015,022006Orig1s016ltr.pdf | |
| 06/21/2016 | SUPPL-14 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020427Orig1s014,022006Orig1s015bl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020427Orig1s014,022006Orig1s015ltr.pdf | |
| 04/03/2014 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020427s013,022006s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020427Orig1s013,022006Orig1s014ltr.pdf | |
| 10/26/2013 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf | |
| 10/26/2013 | SUPPL-11 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf | |
| 10/26/2013 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020427Orig1s010,s011,s012,022006s011,s012,s013ltr.pdf | |
| 12/14/2012 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/2012 | SUPPL-5 | REMS-Modified, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020427s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020427Orig1s005,022006Orig1s006ltr.pdf | |
| 01/18/2011 | SUPPL-2 | Labeling, REMS-Assessment |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020427s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020427s002,022006s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/20/2021 | SUPPL-25 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020427s025,022006s026lbl.pdf | |
| 10/20/2021 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020427s025,022006s026lbl.pdf | |
| 01/24/2020 | SUPPL-21 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020427s021,022006s023lbl.pdf | |
| 07/31/2019 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020427s020,022006s022lbl.pdf | |
| 08/21/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf | |
| 04/27/2017 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020427s016,022006s018lbl.pdf | |
| 06/21/2016 | SUPPL-14 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020427Orig1s014,022006Orig1s015bl.pdf | |
| 09/18/2015 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020427s015,022006s016lbl.pdf | |
| 04/03/2014 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020427s013,022006s014lbl.pdf | |
| 10/26/2013 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf | |
| 10/26/2013 | SUPPL-11 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf | |
| 10/26/2013 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf | |
| 12/11/2012 | SUPPL-5 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020427s005lbl.pdf | |
| 12/11/2012 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020427s005lbl.pdf | |
| 01/18/2011 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020427s002lbl.pdf | |
| 01/18/2011 | SUPPL-2 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020427s002lbl.pdf | |
| 08/21/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020427s000lbl.pdf |
SABRIL
TABLET;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SABRIL | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | Yes | AB | 020427 | LUNDBECK PHARMS LLC |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 210042 | AMNEAL PHARMS |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 215601 | AUROBINDO PHARMA LTD |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 215109 | DEXCEL |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 211539 | DR REDDYS |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 213104 | HIKMA |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 215519 | PROPEL PHARMA |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 209822 | TEVA PHARMS USA |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 214749 | UPSHER SMITH LABS |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 215707 | ZYDUS LIFESCIENCES |