THEA PHARMA INC. FDA Approval NDA 216472

NDA 216472

THEA PHARMA INC.

FDA Drug Application

Application #216472

Documents

Letter2022-12-15
Label2022-12-15

Application Sponsors

NDA 216472THEA PHARMA INC.

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC50MCG/ML0IYUZEHLATANOPROST

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-12-13STANDARD

Submissions Property Types

ORIG1Null6

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
        )

)

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