NDA 215650

DARE BIOSCIENCE INC

FDA Drug Application

Application #215650

Documents

• Label: 2021-12-07
• Letter: 2021-12-08
• Review: 2022-06-01

Application Sponsors

NDA 215650

DARE BIOSCIENCE INC

Marketing Status

• Prescription: 001

Application Products

001

GEL;VAGINAL

2%

0

XACIATO

CLINDAMYCIN PHOSPHATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-12-07

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

DARE BIOSCIENCE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215650
            [companyName] => DARE BIOSCIENCE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"XACIATO","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"2%","dosageForm":"GEL;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/07\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215650s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215650s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-07
        )

)