Application Sponsors
ANDA 202178 | WATSON LABS INC | |
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
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202178
[companyName] => WATSON LABS INC
[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":"09\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-09-01
)
)