ANDA 213377

ANNORA PHARMA

FDA Drug Application

Application #213377

Application Sponsors

ANDA 213377

ANNORA PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SUPPOSITORY;RECTAL

1GM

0

MESALAMINE

MESALAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-03-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ANNORA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213377
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"1GM","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-19
        )

)