ANDA 204476

BAYSHORE PHARMS LLC

FDA Drug Application

Application #204476

Application Sponsors

ANDA 204476

BAYSHORE PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 15MG BASE

0

PRIMAQUINE PHOSPHATE

PRIMAQUINE PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-02-25

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AB

CDER Filings

BAYSHORE PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204476
            [companyName] => BAYSHORE PHARMS LLC
            [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\/25\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-02-25
        )

)