NDA 214900

SCYNEXIS, INC

FDA Drug Application

Application #214900

Documents

• Label: 2021-06-02
• Letter: 2021-06-02
• Review: 2021-06-30
• Letter: 2022-06-16
• Label: 2022-06-16
• Letter: 2022-12-01
• Label: 2022-12-05
• Medication Guide: 2022-12-05

Application Sponsors

NDA 214900

SCYNEXIS, INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

150MG

0

BREXAFEMME

IBREXAFUNGERP CITRATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-06-01	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2022-11-30	PRIORITY

Submissions Property Types

ORIG	1	Null	2
SUPPL	2	Null	6

CDER Filings

SCYNEXIS, INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214900
            [companyName] => SCYNEXIS, INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BREXAFEMME","activeIngredients":"IBREXAFUNGERP CITRATE","strength":"150MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/01\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214900s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/01\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214900s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214900Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-06-01
        )

)