ANDA 212356

STRIDES PHARMA

FDA Drug Application

Application #212356

Documents

• Letter: 2020-03-23

Application Sponsors

ANDA 212356

STRIDES PHARMA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

OINTMENT;TOPICAL

0.05%

0

TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETONIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-01-23

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AT

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212356
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212356Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-01
        )

)