Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021595
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SANCTURA TROSPIUM CHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/28/2004 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21595_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21595ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-595_Sanctura.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/23/2012 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021595s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021595Orig1s008,s009ltr.pdf
07/23/2012 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021595s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021595Orig1s008,s009ltr.pdf
01/31/2011 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021595s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021595s007ltr.pdf
09/14/2011 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021595s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021595s006ltr.pdf
06/01/2009 SUPPL-5 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021595s005lbl.pdf
12/07/2006 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021595s003ltr.pdf
09/05/2006 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021595s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021595s002_ltr.pdf
03/11/2005 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21595s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21595s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/23/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021595s009lbl.pdf
07/23/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021595s008lbl.pdf
09/14/2011 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021595s006lbl.pdf
01/31/2011 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021595s007lbl.pdf
06/01/2009 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021595s005lbl.pdf
09/05/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021595s002lbl.pdf
03/11/2005 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21595s001lbl.pdf
05/28/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21595_lbl.pdf

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