Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020427
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
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
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 209822 TEVA PHARMS USA

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