ANDA 083021

AKORN

FDA Drug Application

Application #083021

Application Sponsors

ANDA 083021

AKORN

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	SOLUTION/DROPS;OPHTHALMIC	10%	0	SODIUM SULFACETAMIDE	SULFACETAMIDE SODIUM
002	SOLUTION/DROPS;OPHTHALMIC	15%	0	SODIUM SULFACETAMIDE	SULFACETAMIDE SODIUM
003	SOLUTION/DROPS;OPHTHALMIC	30%	0	SODIUM SULFACETAMIDE	SULFACETAMIDE SODIUM

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83021
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM SULFACETAMIDE","activeIngredients":"SULFACETAMIDE SODIUM","strength":"10%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SODIUM SULFACETAMIDE","activeIngredients":"SULFACETAMIDE SODIUM","strength":"15%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SODIUM SULFACETAMIDE","activeIngredients":"SULFACETAMIDE SODIUM","strength":"30%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM SULFACETAMIDE","submission":"SULFACETAMIDE SODIUM","actionType":"10%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SODIUM SULFACETAMIDE","submission":"SULFACETAMIDE SODIUM","actionType":"15%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SODIUM SULFACETAMIDE","submission":"SULFACETAMIDE SODIUM","actionType":"30%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)