HETERO LABS LTD III FDA Approval ANDA 202784

ANDA 202784

HETERO LABS LTD III

FDA Drug Application

Application #202784

Documents

Letter2015-09-23
Label2015-11-25

Application Sponsors

ANDA 202784HETERO LABS LTD III

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASE0ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
002CAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASE0ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM

FDA Submissions

UNKNOWN; ORIG1AP2015-09-21

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202784
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 40MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/21\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202784Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202784Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202784Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2015-09-21
        )

)

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