ANDA 208797

INVATECH

FDA Drug Application

Application #208797

Application Sponsors

ANDA 208797

INVATECH

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

60MG/5ML

0

PYRIDOSTIGMINE BROMIDE

PYRIDOSTIGMINE BROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-01-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

ELYSIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208797
            [companyName] => ELYSIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"PYRIDOSTIGMINE BROMIDE","activeIngredients":"PYRIDOSTIGMINE BROMIDE","strength":"60MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-09
        )

)