ANDA 205258

APOTEX

FDA Drug Application

Application #205258

Documents

• Letter: 2014-04-04

Application Sponsors

ANDA 205258

APOTEX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

400MG

0

NEVIRAPINE

NEVIRAPINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-04-03

STANDARD

Submissions Property Types

ORIG

1

Null

19

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205258
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEVIRAPINE","activeIngredients":"NEVIRAPINE","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/03\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205258Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-04-03
        )

)