ANDA 203924

ALVOGEN INC

FDA Drug Application

Application #203924

Documents

• Letter: 2014-02-10

Application Sponsors

ANDA 203924

ALVOGEN INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 15MG BASE

0

PRIMAQUINE PHOSPHATE

PRIMAQUINE PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-02-03

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AB

CDER Filings

ALVOGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203924
            [companyName] => ALVOGEN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRIMAQUINE PHOSPHATE","activeIngredients":"PRIMAQUINE PHOSPHATE","strength":"EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/03\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203924Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-02-03
        )

)