Application Sponsors
ANDA 208667 | TELIGENT PHARMA INC | |
Marketing Status
Application Products
001 | LOTION;TOPICAL | 0.05% | 0 | CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-11-29 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
TELIGENT PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208667
[companyName] => TELIGENT PHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/06\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-09-06
)
)