ANDA 206716

NOVAST LABS

FDA Drug Application

Application #206716

Application Sponsors

ANDA 206716

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;TOPICAL

5%

0

MAFENIDE ACETATE

MAFENIDE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-07-31

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206716
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAFENIDE ACETATE","activeIngredients":"MAFENIDE ACETATE","strength":"5%","dosageForm":"FOR SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-31
        )

)