ANDA 208362

AMRING PHARMS

FDA Drug Application

Application #208362

Documents

• Letter: 2017-08-29

Application Sponsors

ANDA 208362

AMRING PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SUPPOSITORY;RECTAL

1GM

0

MESALAMINE

MESALAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AMRING PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208362
            [companyName] => AMRING PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"1GM","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/21\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208362Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-21
        )

)