Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022103
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SANCTURA XR TROSPIUM CHLORIDE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No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
08/03/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022103s000tr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022103s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/17/2012 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022103s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022103Orig1s005ltr.pdf
01/31/2011 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022103s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022103s004ltr.pdf
09/14/2011 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022103s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022103s003ltr.pdf
06/01/2009 SUPPL-2 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022103s002lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/17/2012 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022103s005lbl.pdf
09/14/2011 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022103s003lbl.pdf
01/31/2011 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022103s004lbl.pdf
06/01/2009 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022103s002lbl.pdf

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