ANDA 204737

ALVOGEN

FDA Drug Application

Application #204737

Documents

• Letter: 2015-07-07

Application Sponsors

ANDA 204737

ALVOGEN

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

180MG

0

PYRIDOSTIGMINE BROMIDE

PYRIDOSTIGMINE BROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-06-26

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204737
            [companyName] => ALVOGEN
            [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":"06\/26\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204737Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-06-26
        )

)