ANDA 211694

NOVITIUM PHARMA

FDA Drug Application

Application #211694

Documents

• Letter: 2019-03-12

Application Sponsors

ANDA 211694

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

60MG/5ML

0

PYRIDOSTIGMINE BROMIDE

PYRIDOSTIGMINE BROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211694
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PYRIDOSTIGMINE BROMIDE","activeIngredients":"PYRIDOSTIGMINE BROMIDE","strength":"60MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211694Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-08
        )

)