EVOFEM INC FDA Approval NDA 208352

NDA 208352

EVOFEM INC

FDA Drug Application

Application #208352

Documents

Label2020-05-22
Letter2020-05-28

Application Sponsors

NDA 208352EVOFEM INC

Marketing Status

Prescription001

Application Products

001GEL;VAGINAL5G2PHEXXILACTIC ACID;CITRIC ACID;POTASSIUM BITARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2020-05-22STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

EVOFEM INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208352
            [companyName] => EVOFEM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHEXXI","activeIngredients":"LACTIC ACID;CITRIC ACID;POTASSIUM BITARTRATE","strength":"5G","dosageForm":"GEL;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"05\/22\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208352s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/22\/2020","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\\\/2020\\\/208352s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-22
        )

)

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