ANDA 040607

SAPTALIS PHARMS

FDA Drug Application

Application #040607

Application Sponsors

ANDA 040607

SAPTALIS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OTIC

2%

0

ACETIC ACID

ACETIC ACID, GLACIAL

FDA Submissions

ORIG

1

AP

2005-02-24

TE Codes

001

Prescription

AT

CDER Filings

SAPTALIS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40607
            [companyName] => SAPTALIS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETIC ACID","activeIngredients":"ACETIC ACID, GLACIAL","strength":"2%","dosageForm":"SOLUTION\/DROPS;OTIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETIC ACID","submission":"ACETIC ACID, GLACIAL","actionType":"2%","submissionClassification":"SOLUTION\/DROPS;OTIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)