NDA 208352

EVOFEM INC

FDA Drug Application

Application #208352

Documents

• Label: 2020-05-22
• Letter: 2020-05-28
• Review: 2020-11-03
• Letter: 2022-02-09
• Label: 2022-02-10
• Label: 2022-02-11

Application Sponsors

NDA 208352

EVOFEM INC

Marketing Status

• Prescription: 001

Application Products

001

GEL;VAGINAL

5G

2

PHEXXI

LACTIC ACID;CITRIC ACID;POTASSIUM BITARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2020-05-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-02-08	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	7

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
        )

)