NOVITIUM PHARMA FDA Approval NDA 214581

NDA 214581

NOVITIUM PHARMA

FDA Drug Application

Application #214581

Documents

Letter2022-01-19
Label2022-01-20
Review2022-10-17
Letter2023-01-13
Label2023-01-13

Application Sponsors

NDA 214581NOVITIUM PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET; ORAL200MG2HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE
002TABLET; ORAL300MG2HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-01-14STANDARD
LABELING; LabelingSUPPL4AP2023-01-12STANDARD

Submissions Property Types

ORIG1Null15
SUPPL4Null6

TE Codes

001PrescriptionTBD
002PrescriptionTBD

CDER Filings

NOVITIUM PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214581
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYCHLOROQUINE SULFATE","activeIngredients":"HYDROXYCHLOROQUINE SULFATE","strength":"200MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"HYDROXYCHLOROQUINE SULFATE","activeIngredients":"HYDROXYCHLOROQUINE SULFATE","strength":"300MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"01\/14\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214581s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/14\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214581s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214581Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-01-14
        )

)

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