ANDA 065024

FERA PHARMS LLC

FDA Drug Application

Application #065024

Documents

• Review: 2007-04-02

Application Sponsors

ANDA 065024

FERA PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;OPHTHALMIC

EQ 0.3% BASE

0

GENTAMICIN SULFATE

GENTAMICIN SULFATE

FDA Submissions

ORIG

1

AP

2004-07-30

TE Codes

001

Prescription

AT

CDER Filings

FERA PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65024
            [companyName] => FERA PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 0.3% BASE","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GENTAMICIN SULFATE","submission":"GENTAMICIN SULFATE","actionType":"EQ 0.3% BASE","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)