ANDA 212702

AMNEAL PHARMS LLC

FDA Drug Application

Application #212702

Documents

• Letter: 2020-03-23

Application Sponsors

ANDA 212702

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

60MG/5ML

0

PYRIDOSTIGMINE BROMIDE

PYRIDOSTIGMINE BROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-01-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212702
            [companyName] => AMNEAL
            [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\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212702Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-10
        )

)