Documents
Application Sponsors
| NDA 021228 | PHARMACIA AND UPJOHN | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE, EXTENDED RELEASE;ORAL | 2MG | 1 | DETROL LA | TOLTERODINE TARTRATE |
| 002 | CAPSULE, EXTENDED RELEASE;ORAL | 4MG | 1 | DETROL LA | TOLTERODINE TARTRATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2001-09-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2001-12-17 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2003-07-21 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2004-01-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2004-04-14 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2005-10-20 | UNKNOWN |
| LABELING; Labeling | SUPPL | 8 | AP | 2005-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2007-03-16 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2008-09-11 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2010-01-05 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2011-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2012-08-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2014-07-28 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2018-07-13 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 6 | Null | 26 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
UPJOHN
cder:Array
(
[0] => Array
(
[ApplNo] => 21228
[companyName] => UPJOHN
[docInserts] => ["",""]
[products] => [{"drugName":"DETROL LA","activeIngredients":"TOLTERODINE TARTRATE","strength":"2MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"DETROL LA","activeIngredients":"TOLTERODINE TARTRATE","strength":"4MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/13\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021228s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2012","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021228s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2011","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021228s016lbl.pdf\"}]","notes":""},{"actionDate":"01\/05\/2010","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021228s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2007","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021228Orig1s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2005","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021228s007lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2005","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021228s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2004","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21228se8-006_detrol_lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2001","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21228s1lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21228lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DETROL LA","submission":"TOLTERODINE TARTRATE","actionType":"2MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DETROL LA","submission":"TOLTERODINE TARTRATE","actionType":"4MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-07-13
)
)