Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022006
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/PACKET | FOR SOLUTION;ORAL | Prescription | AA | 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 3 - New Dosage Form | PRIORITY; Orphan |
Letter (PDF)
Review Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022006s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022006s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022006s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/12/2024 | SUPPL-28 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022006Orig1s028; 020427Orig1s027ltr.pdf |
| 10/12/2022 | SUPPL-27 | 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-26 | 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-25 | 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 |
| 09/12/2019 | SUPPL-24 | 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-23 | 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,%20022006Orig1s023ltr.pdf | |
| 07/31/2019 | SUPPL-22 | 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-21 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020427Orig1s019,%20022006Orig1s021ltr.pdf |
| 08/21/2018 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
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-19 | 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-18 | Labeling-Container/Carton Labels |
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 | |
| 11/03/2015 | SUPPL-17 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022006Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022006Orig1s017ltr.pdf | |
| 09/18/2015 | SUPPL-16 | 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-15 | 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-14 | 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-13 | Efficacy-New Indication |
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-12 | Efficacy-Labeling Change With Clinical Data |
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 | 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 | |
| 12/11/2012 | SUPPL-6 | REMS-Modified, Labeling-Medication Guide |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022006s006lbl.pdf | |
| 01/18/2011 | SUPPL-2 | Labeling, REMS-Assessment |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022006s002lbl.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-26 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020427s025,022006s026lbl.pdf | |
| 10/20/2021 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020427s025,022006s026lbl.pdf | |
| 01/24/2020 | SUPPL-23 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020427s021,022006s023lbl.pdf | |
| 07/31/2019 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020427s020,022006s022lbl.pdf | |
| 08/21/2018 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf | |
| 08/21/2018 | SUPPL-20 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf | |
| 04/27/2017 | SUPPL-18 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020427s016,022006s018lbl.pdf | |
| 06/21/2016 | SUPPL-15 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020427Orig1s014,022006Orig1s015bl.pdf | |
| 11/03/2015 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022006Orig1s017lbl.pdf | |
| 09/18/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020427s015,022006s016lbl.pdf | |
| 04/03/2014 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020427s013,022006s014lbl.pdf | |
| 10/26/2013 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf | |
| 10/26/2013 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf | |
| 10/26/2013 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020427s010s011s012,022006s011s012s013lbl.pdf | |
| 12/11/2012 | SUPPL-6 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022006s006lbl.pdf | |
| 12/11/2012 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022006s006lbl.pdf | |
| 01/18/2011 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022006s002lbl.pdf | |
| 01/18/2011 | SUPPL-2 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022006s002lbl.pdf |
SABRIL
FOR SOLUTION;ORAL; 500MG/PACKET
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SABRIL | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | Yes | AA | 022006 | LUNDBECK PHARMS LLC |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 213375 | ALKEM LABS LTD |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 210155 | AMNEAL PHARMS |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 213519 | ANNORA PHARMA |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 213899 | AUROBINDO PHARMA LTD |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 214992 | DEXCEL |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 211481 | DR REDDYS |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 208218 | ENDO OPERATIONS |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 211592 | INVAGEN PHARMS |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 215363 | MSN |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 213390 | PROPEL PHARMA |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 209824 | TEVA PHARMS USA |
| VIGADRONE | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 210196 | AUCTA |
| VIGPODER | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 214961 | PYROS PHARMS |