GLENMARK PHARMS LTD FDA Approval ANDA 207985

ANDA 207985

GLENMARK PHARMS LTD

FDA Drug Application

Application #207985

Application Sponsors

ANDA 207985GLENMARK PHARMS LTD

Marketing Status

None (Tentative Approval)001

Application Products

001CAPSULE;ORAL0.5MG0FINGOLIMODFINGOLIMOD

FDA Submissions

UNKNOWN; ORIG1TA2017-03-17STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207985
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINGOLIMOD HYDROCHLORIDE","activeIngredients":"FINGOLIMOD HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-18
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.