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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021518
Company: ASTELLAS

Products on NDA 021518

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VESICARE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	AB	Yes	No
VESICARE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021518

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/19/2004	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21518lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21518ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-518_VesiCare.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2019	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021518s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021518Orig1s018ltr.pdf
05/26/2020	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021518s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021518Orig1s017ltr.pdf
10/09/2013	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021518s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021518Orig1s016ltr.pdf
03/29/2013	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021518s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021518Orig1s015ltr.pdf
08/03/2012	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518Orig1s014ltr.pdf
07/13/2012	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518S013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518Orig1s013ltr.pdf
01/17/2012	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518s012ltr.pdf
06/07/2012	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021518s011ltr.pdf
03/10/2011	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021518s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021518s010ltr.pdf
07/12/2010	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021518s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021518s008ltr.pdf
11/18/2008	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021518s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021518s007ltr.pdf
10/29/2008	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021518s006ltr.pdf
02/08/2008	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021518s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021518s004ltr.pdf
07/12/2007	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021518s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021518s003ltr.pdf
04/24/2007	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 021518

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/26/2020	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021518s017lbl.pdf
04/30/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021518s018lbl.pdf
10/09/2013	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021518s016lbl.pdf
03/29/2013	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021518s015lbl.pdf
08/03/2012	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518s014lbl.pdf
07/13/2012	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518S013lbl.pdf
06/07/2012	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518s011lbl.pdf
01/17/2012	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021518s012lbl.pdf
03/10/2011	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021518s010lbl.pdf
07/12/2010	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021518s008lbl.pdf
11/18/2008	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021518s007lbl.pdf
02/08/2008	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021518s004lbl.pdf
07/12/2007	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021518s003lbl.pdf
11/19/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21518lbl.pdf

Therapeutic Equivalents for NDA 021518

VESICARE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	205575	ALEMBIC
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	210224	ALKEM LABS LTD
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	215761	ANNORA PHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	206817	AUROBINDO PHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	210281	AUSTARPHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	210582	CHARTWELL RX
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	212214	ESJAY PHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	209239	GLENMARK SPECLT
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	205484	JUBILANT GENERICS
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	204374	MACLEODS PHARMS LTD
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	210688	MSN
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	209333	QILU
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	211423	RISING
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	211657	SCIEGEN PHARMS INC
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	091464	TEVA PHARMS USA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	211701	UNICHEM
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	202551	WATSON LABS INC
VESICARE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	Yes	AB	021518	ASTELLAS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	205575	ALEMBIC
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	210224	ALKEM LABS LTD
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	215761	ANNORA PHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	206817	AUROBINDO PHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	210281	AUSTARPHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	210582	CHARTWELL RX
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	212214	ESJAY PHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	209239	GLENMARK SPECLT
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	205484	JUBILANT GENERICS
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	204374	MACLEODS PHARMS LTD
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	210688	MSN
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	209333	QILU
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	211423	RISING
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	211657	SCIEGEN PHARMS INC
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	091464	TEVA PHARMS USA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	211701	UNICHEM
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	202551	WATSON LABS INC
VESICARE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	Yes	AB	021518	ASTELLAS

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