GLENMARK PHARMS LTD FDA Approval ANDA 202190

ANDA 202190

GLENMARK PHARMS LTD

FDA Drug Application

Application #202190

Documents

Letter2018-08-20

Application Sponsors

ANDA 202190GLENMARK PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2018-07-16
LABELING; LabelingSUPPL2AP2020-03-16STANDARD
LABELING; LabelingSUPPL3AP2021-03-31STANDARD
LABELING; LabelingSUPPL5AP2022-09-28STANDARD
LABELING; LabelingSUPPL7AP2022-11-02STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL3Null7
SUPPL5Null7
SUPPL7Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

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
        )

)

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