NDA 214032

TELIX PHARMACEUTICALS US INC

FDA Drug Application

Application #214032

Documents

• Letter: 2021-12-21
• Review: 2022-08-03

Application Sponsors

NDA 214032

TELIX PHARMACEUTICALS US INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

25MCG;10MCG

0

ILLUCCIX

GOZETOTIDE;D-MANNOSE

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination

ORIG

1

AP

2021-12-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

TELIX PHARMACEUTICALS US INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214032
            [companyName] => TELIX PHARMACEUTICALS US INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ILLUCCIX","activeIngredients":"GOZETOTIDE;D-MANNOSE","strength":"25MCG;10MCG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214032Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-17
        )

)