SINTETICA SA FDA Approval NDA 216227

NDA 216227

SINTETICA SA

FDA Drug Application

Application #216227

Documents

Letter2022-09-28
Label2022-09-28

Application Sponsors

NDA 216227SINTETICA SA

Marketing Status

Prescription001

Application Products

001GEL;OPHTHALMIC3%0IHEEZOCHLOROPROCAINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2022-09-27STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

SINTETICA SA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216227
            [companyName] => SINTETICA SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IHEEZO","activeIngredients":"CHLOROPROCAINE HYDROCHLORIDE","strength":"3%","dosageForm":"GEL;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/27\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216227s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216227s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216227Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-09-27
        )

)

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