GLENMARK PHARMS LTD FDA Approval ANDA 079019

ANDA 079019

GLENMARK PHARMS LTD

FDA Drug Application

Application #079019

Documents

Letter2017-06-02

Application Sponsors

ANDA 079019GLENMARK PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001CAPSULE;ORAL10MG0ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDE
002CAPSULE;ORAL18MG0ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDE
003CAPSULE;ORAL25MG0ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDE
004CAPSULE;ORAL40MG0ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDE
005CAPSULE;ORAL60MG0ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDE
006CAPSULE;ORAL80MG0ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDE
007CAPSULE;ORAL100MG0ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2017-05-30

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB
007PrescriptionAB

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79019
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"18MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"60MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"80MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"18MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"60MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"80MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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