NDA 216472

THEA PHARMA INC.

FDA Drug Application

Application #216472

Documents

• Letter: 2022-12-15
• Label: 2022-12-15

Application Sponsors

NDA 216472

THEA PHARMA INC.

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

50MCG/ML

0

IYUZEH

LATANOPROST

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-12-13

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

THEA PHARMA INC.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216472
            [companyName] => THEA PHARMA INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"IYUZEH","activeIngredients":"LATANOPROST","strength":"50MCG\/ML","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/13\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216472s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/13\/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\\\/216472s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216472Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-12-13
        )

)