Application Sponsors
ANDA 090974 | PERRIGO ISRAEL | |
Marketing Status
Application Products
001 | SHAMPOO;TOPICAL | 0.05% | 0 | CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2012-08-09 | |
LABELING; Labeling | SUPPL | 5 | AP | 2019-09-06 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
PERRIGO ISRAEL
cder:Array
(
[0] => Array
(
[ApplNo] => 90974
[companyName] => PERRIGO ISRAEL
[docInserts] => ["",""]
[products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"SHAMPOO;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CLOBETASOL PROPIONATE","submission":"CLOBETASOL PROPIONATE","actionType":"0.05%","submissionClassification":"SHAMPOO;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)