Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 021518
Company: ASTELLAS
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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