Documents
Application Sponsors
NDA 215025 | MAIA PHARMS INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 10% | 0 | SODIUM PHENYLACETATE; SODIUM BENZOATE | SODIUM PHENYLACETATE;SODIUM BENZOATE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2021-06-10 | STANDARD |
Submissions Property Types
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
)
)