NDA 213690

FOAMIX

FDA Drug Application

Application #213690

Documents

• Label: 2020-05-29
• Letter: 2020-06-01
• Review: 2020-10-20

Application Sponsors

NDA 213690

FOAMIX

Marketing Status

• Prescription: 001

Application Products

001

FOAM; TOPICAL

1.5%

2

ZILXI

MINOCYCLINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2020-05-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

FOAMIX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213690
            [companyName] => FOAMIX
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZILXI","activeIngredients":"MINOCYCLINE","strength":"1.5%","dosageForm":"FOAM; TOPICAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"05\/28\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213690s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213690s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213690Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-28
        )

)