HETERO LABS LTD III FDA Approval ANDA 207961

ANDA 207961

HETERO LABS LTD III

FDA Drug Application

Application #207961

Documents

Letter2020-06-04

Application Sponsors

ANDA 207961HETERO LABS LTD III

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORALEQ 75MG BASE0DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATE
002CAPSULE;ORALEQ 150MG BASE0DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATE

FDA Submissions

UNKNOWN; ORIG1AP2020-05-06STANDARD
UNKNOWN; ORIG2TA2020-05-06STANDARD

Submissions Property Types

ORIG1Null7
ORIG2Null31

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207961
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/06\/2020","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207961Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-06
        )

)

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