ANDA 209990

AMNEAL PHARMS LLC

FDA Drug Application

Application #209990

Application Sponsors

ANDA 209990

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

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

2018-02-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209990
            [companyName] => AMNEAL
            [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":"02\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-02-15
        )

)