ANDA 205464

RISING

FDA Drug Application

Application #205464

Application Sponsors

ANDA 205464

RISING

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

180MG

0

PYRIDOSTIGMINE BROMIDE

PYRIDOSTIGMINE BROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-08-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205464
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"PYRIDOSTIGMINE BROMIDE","activeIngredients":"PYRIDOSTIGMINE BROMIDE","strength":"180MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/15\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-15
        )

)