ANDA 206623

MAYNE PHARMA

FDA Drug Application

Application #206623

Documents

• Letter: 2016-04-11

Application Sponsors

ANDA 206623

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

3MG

0

BUDESONIDE

BUDESONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-04-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206623
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"3MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/08\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206623Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-04-08
        )

)