WATSON LABS INC FDA Approval ANDA 202178

ANDA 202178

WATSON LABS INC

FDA Drug Application

Application #202178

Application Sponsors

ANDA 202178WATSON LABS INC

Marketing Status

Prescription001
Prescription002

Application Products

001FOR SUSPENSION;ORAL1.875GM/PACKET0COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE
002FOR SUSPENSION;ORAL3.75GM/PACKET0COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE

FDA Submissions

ORIG1AP2020-09-01

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

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
        )

)

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