Application Sponsors
ANDA 214181 | MACLEODS PHARMS LTD | |
Marketing Status
Application Products
001 | CREAM;TOPICAL | 100,000 UNITS/GM;0.1% | 0 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-07-13 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 214181
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"NYSTATIN AND TRIAMCINOLONE ACETONIDE","activeIngredients":"NYSTATIN; TRIAMCINOLONE ACETONIDE","strength":"100,000 UNITS\/GM;0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-07-13
)
)