NDA 211882

BAUSCH

FDA Drug Application

Application #211882

Documents

• Label: 2019-12-19
• Letter: 2019-12-20
• Pediatric Medical Review: 1900-01-01
• Review: 2020-07-10

Application Sponsors

NDA 211882

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.045%

1

ARAZLO

TAZAROTENE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2019-12-18

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211882
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARAZLO","activeIngredients":"TAZAROTENE","strength":"0.045%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/18\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211882s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/18\/2019","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\\\/2019\\\/211882s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211882Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211882Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-12-18
        )

)