APOTEX INC FDA Approval ANDA 203640

ANDA 203640

APOTEX INC

FDA Drug Application

Application #203640

Application Sponsors

ANDA 203640APOTEX INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003

Application Products

001CAPSULE;ORALEQ 50MG BASE0NILOTINIB HYDROCHLORIDENILOTINIB HYDROCHLORIDE
002CAPSULE;ORALEQ 150MG BASE0NILOTINIB HYDROCHLORIDENILOTINIB HYDROCHLORIDE
003CAPSULE;ORALEQ 200MG BASE0NILOTINIB HYDROCHLORIDENILOTINIB HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2022-06-10STANDARD

Submissions Property Types

ORIG1Null19

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203640
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NILOTINIB HYDROCHLORIDE","activeIngredients":"NILOTINIB HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"NILOTINIB HYDROCHLORIDE","activeIngredients":"NILOTINIB HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"NILOTINIB HYDROCHLORIDE","activeIngredients":"NILOTINIB HYDROCHLORIDE","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/10\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-10
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.