Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021518
Company: ASTELLAS
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
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
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-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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) 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

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 205483 AJANTA PHARMA LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 205575 ALEMBIC PHARMS LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 210224 ALKEM LABS LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 209719 AMNEAL PHARMS CO
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 209818 BRECKENRIDGE
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 210582 CELLTRION
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 209839 CIPLA
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 209239 GLENMARK PHARMS INC
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 210281 JIANGXI BOYA SEEHOT
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 210688 MSN LABS PVT LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 209333 QILU PHARM CO LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 211657 SCIEGEN PHARMS INC
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 212214 STRIDES PHARMA
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 LABS LTD
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 205483 AJANTA PHARMA LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 205575 ALEMBIC PHARMS LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 210224 ALKEM LABS LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 209719 AMNEAL PHARMS CO
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 209818 BRECKENRIDGE
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 210582 CELLTRION
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 209839 CIPLA
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 209239 GLENMARK PHARMS INC
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 210281 JIANGXI BOYA SEEHOT
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 210688 MSN LABS PVT LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 209333 QILU PHARM CO LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 211657 SCIEGEN PHARMS INC
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 212214 STRIDES PHARMA
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 LABS LTD
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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