ANDA 065006

AKORN INC

FDA Drug Application

Application #065006

Documents

• Letter: 1998-12-17

Application Sponsors

ANDA 065006

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

10,000 UNITS/ML;EQ 1MG BASE/ML

0

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

FDA Submissions

ORIG

1

AP

1998-12-17

Submissions Property Types

SUPPL

1

Null

0

TE Codes

001

Prescription

AT

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65006
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE","activeIngredients":"POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","strength":"10,000 UNITS\/ML;EQ 1MG BASE\/ML","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE","submission":"POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","actionType":"10,000 UNITS\/ML;EQ 1MG BASE\/ML","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)