ANDA 216692

COSETTE

FDA Drug Application

Application #216692

Application Sponsors

ANDA 216692

COSETTE

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

1%

0

METRONIDAZOLE

METRONIDAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

COSETTE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216692
            [companyName] => COSETTE
            [docInserts] => ["",""]
            [products] => [{"drugName":"METRONIDAZOLE","activeIngredients":"METRONIDAZOLE","strength":"1%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/23\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-23
        )

)