Application Sponsors
ANDA 208108 | GLENMARK PHARMS LTD | |
Marketing Status
Application Products
001 | GEL;TOPICAL | 0.1%;2.5% | 0 | ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-11-08 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
GLENMARK PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 208108
[companyName] => GLENMARK PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ADAPALENE AND BENZOYL PEROXIDE","activeIngredients":"ADAPALENE; BENZOYL PEROXIDE","strength":"0.1%;2.5%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-11-08
)
)