ANDA 076574

TELIGENT PHARMA INC

FDA Drug Application

Application #076574

Documents

• Review: 2008-07-31

Application Sponsors

ANDA 076574

TELIGENT PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%

0

ECONAZOLE NITRATE

ECONAZOLE NITRATE

FDA Submissions

ORIG

1

AP

2004-12-17

TE Codes

001

Prescription

AB

CDER Filings

TELIGENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76574
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ECONAZOLE NITRATE","activeIngredients":"ECONAZOLE NITRATE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ECONAZOLE NITRATE","submission":"ECONAZOLE NITRATE","actionType":"1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)