ANDA 209815

NOVITIUM PHARMA

FDA Drug Application

Application #209815

Application Sponsors

ANDA 209815

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

1%

0

CLOTRIMAZOLE

CLOTRIMAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209815
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOTRIMAZOLE","activeIngredients":"CLOTRIMAZOLE","strength":"1%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-15
        )

)