NDA 210850

MAIA PHARMS INC

FDA Drug Application

Application #210850

Documents

• Letter: 2018-02-26
• Label: 2022-11-23
• Letter: 2022-11-25

Application Sponsors

NDA 210850

MAIA PHARMS INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INJECTION

5MCG/VIAL

0

SINCALIDE

SINCALIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2018-02-23

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

MAIA PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210850
            [companyName] => MAIA PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SINCALIDE","activeIngredients":"SINCALIDE","strength":"5MCG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/23\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210850Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-02-23
        )

)