NDA 209355

BAUSCH

FDA Drug Application

Application #209355

Documents

• Letter: 2018-11-15
• Label: 2018-11-08
• Review: 2018-12-26

Application Sponsors

NDA 209355

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.01%

1

BRYHALI

HALOBETASOL PROPIONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2018-11-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209355
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRYHALI","activeIngredients":"HALOBETASOL PROPIONATE","strength":"0.01%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/06\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209355s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/06\/2018","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\\\/2018\\\/209355s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209355Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/209355Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-11-06
        )

)