ANDA 204154

EDENBRIDGE PHARMS

FDA Drug Application

Application #204154

Documents

• Label: 2014-10-30
• Letter: 2014-10-28

Application Sponsors

ANDA 204154

EDENBRIDGE PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

3MG

0

IVERMECTIN

IVERMECTIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-10-24

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AB

CDER Filings

EDENBRIDGE PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204154
            [companyName] => EDENBRIDGE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"IVERMECTIN","activeIngredients":"IVERMECTIN","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/24\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204154Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/24\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204154Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204154Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2014-10-24
        )

)