ANDA 204651

TARO

FDA Drug Application

Application #204651

Application Sponsors

ANDA 204651

TARO

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

1%

0

METRONIDAZOLE

METRONIDAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-03-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204651
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"METRONIDAZOLE","activeIngredients":"METRONIDAZOLE","strength":"1%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/14\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-14
        )

)