Documents
Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SANCTURA | TROSPIUM CHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2004-05-28 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2006-09-05 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2006-12-07 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2009-06-01 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2011-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2011-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2012-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2012-07-23 | STANDARD |
Submissions Property Types
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 6 |
CDER Filings
ALLERGAN
cder:Array
(
[0] => Array
(
[ApplNo] => 21595
[companyName] => ALLERGAN
[docInserts] => ["",""]
[products] => [{"drugName":"SANCTURA","activeIngredients":"TROSPIUM CHLORIDE","strength":"20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"07\/23\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021595s009lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021595s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2011","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021595s006lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2011","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021595s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/01\/2009","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021595s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/05\/2006","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021595s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2005","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/21595s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/28\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21595_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SANCTURA","submission":"TROSPIUM CHLORIDE","actionType":"20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2012-07-23
)
)