MAIA PHARMS INC FDA Approval NDA 215025

NDA 215025

MAIA PHARMS INC

FDA Drug Application

Application #215025

Documents

Label2021-06-11
Letter2021-06-14

Application Sponsors

NDA 215025MAIA PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION10%0SODIUM PHENYLACETATE; SODIUM BENZOATESODIUM PHENYLACETATE;SODIUM BENZOATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2021-06-10STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

MAIA PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215025
            [companyName] => MAIA PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM PHENYLACETATE; SODIUM BENZOATE","activeIngredients":"SODIUM PHENYLACETATE;SODIUM BENZOATE","strength":"10%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/10\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215025s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/10\/2021","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\\\/2021\\\/215025s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215025Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-06-10
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.