Documents
Application Sponsors
| ANDA 202190 | GLENMARK PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | FOR SUSPENSION;ORAL | 1.875GM/PACKET | 0 | COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE |
| 002 | FOR SUSPENSION;ORAL | 3.75GM/PACKET | 0 | COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-07-16 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-03-16 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-03-31 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2022-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-11-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 7 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
GLENMARK PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202190
[companyName] => GLENMARK PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"COLESEVELAM HYDROCHLORIDE","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"1.875GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"COLESEVELAM HYDROCHLORIDE","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"3.75GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202190Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/16\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/16\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-03-16
)
)