Application Sponsors
ANDA 200830 | WATSON LABS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 625MG | 0 | COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2020-09-02 | |
Submissions Property Types
TE Codes
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 200830
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"COLESEVELAM HYDROCHLORIDE","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"625MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-09-02
)
)