Documents
Application Sponsors
ANDA 210077 | STRIDES PHARMA | |
Marketing Status
Application Products
001 | OINTMENT;TOPICAL | 100,000 UNITS/GM;0.1% | 0 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-01-29 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 210077
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"NYSTATIN AND TRIAMCINOLONE ACETONIDE","activeIngredients":"NYSTATIN; TRIAMCINOLONE ACETONIDE","strength":"100,000 UNITS\/GM;0.1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/29\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210077Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-01-29
)
)