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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021595
Company: ALLERGAN

Products on NDA 021595

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SANCTURA	TROSPIUM CHLORIDE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021595

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

Labels for NDA 021595

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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