Application Sponsors
Marketing Status
Application Products
001 | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | 0 | TESTOSTERONE | TESTOSTERONE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-09-23 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
TWI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 209390
[companyName] => TWI PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"1.62% (20.25MG\/1.25GM ACTUATION)","dosageForm":"GEL, METERED;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-09-23
)
)