ANDA 207188

PRINSTON INC

FDA Drug Application

Application #207188

Documents

• Letter: 2017-09-07

Application Sponsors

ANDA 207188

PRINSTON INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 7.5MG BASE

0

PAROXETINE MESYLATE

PAROXETINE MESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-08-18

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207188
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAROXETINE MESYLATE","activeIngredients":"PAROXETINE MESYLATE","strength":"EQ 7.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207188Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-18
        )

)