ANDA 202065

SANDOZ INC

FDA Drug Application

Application #202065

Documents

• Letter: 2017-08-07

Application Sponsors

ANDA 202065

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

SUPPOSITORY;RECTAL

1GM

0

MESALAMINE

MESALAMINE

FDA Submissions

ORIG

1

AP

2019-06-12

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202065
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"1GM","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202065Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-12
        )

)