NDA 214581

NOVITIUM PHARMA

FDA Drug Application

Application #214581

Documents

• Letter: 2022-01-19
• Label: 2022-01-20
• Review: 2022-10-17
• Letter: 2023-01-13
• Label: 2023-01-13

Application Sponsors

NDA 214581

NOVITIUM PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET; ORAL	200MG	2	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE
002	TABLET; ORAL	300MG	2	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2022-01-14	STANDARD
LABELING; Labeling	SUPPL	4	AP	2023-01-12	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	6

TE Codes

001	Prescription	TBD
002	Prescription	TBD

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
        )

)