Documents
Application Sponsors
Marketing Status
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
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
)
)