Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | FOR SUSPENSION;ORAL | 1.875GM/PACKET | 1 | WELCHOL | COLESEVELAM HYDROCHLORIDE |
| 002 | FOR SUSPENSION;ORAL | 3.75GM/PACKET | 1 | WELCHOL | COLESEVELAM HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2009-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2010-09-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 7 | AP | 2011-07-18 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2012-01-03 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2012-07-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2012-11-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2013-02-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2013-02-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2013-06-28 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2013-03-07 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2013-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2013-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2014-03-11 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2014-01-22 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2019-01-16 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2019-04-10 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2019-05-21 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2020-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2020-07-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2021-10-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 23 | Null | 33 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 27 | Null | 15 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 29 | Null | 6 |
TE Codes
CDER Filings
DAIICHI SANKYO
cder:Array
(
[0] => Array
(
[ApplNo] => 22362
[companyName] => DAIICHI SANKYO
[docInserts] => ["",""]
[products] => [{"drugName":"WELCHOL","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"1.875GM\/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"WELCHOL","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"3.75GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/29\/2020","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022362s028,021176s048lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2020","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022362s027,021776s047,210895s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021176s045,022362s025lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022362Orig1s024lbl.pdf\"}]","notes":""},{"actionDate":"01\/16\/2019","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021176s044,022362s023lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2014","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021176s037,022362s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021176s034s038,022362s015s017s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021176s034s038,022362s015s017s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-17","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021176s034s038,022362s015s017s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021176s034s038,022362s015s017s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021176s034s038,022362s015s017s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2012","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021176s030,022362s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/03\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021176s029,022362s009lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2011","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022362s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2010","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021176s027,022362s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022362lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"WELCHOL","submission":"COLESEVELAM HYDROCHLORIDE","actionType":"1.875GM\/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"WELCHOL","submission":"COLESEVELAM HYDROCHLORIDE","actionType":"3.75GM\/PACKET","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-07-29
)
)