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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022006
Company: LUNDBECK PHARMS LLC

Medication Guide

REMS

Summary Review

Products on NDA 022006

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022006

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
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-Medication Guide, 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-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	Labeling-Medication Guide, REMS-Modified	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

Labels for NDA 022006

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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf
08/21/2018	SUPPL-20	Labeling-Package Insert	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	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022006s006lbl.pdf
12/11/2012	SUPPL-6	REMS-Modified	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

Therapeutic Equivalents for NDA 022006

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	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	208218	PAR PHARM INC
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

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