ANDA 207065

ACCORD HLTHCARE

FDA Drug Application

Application #207065

Application Sponsors

ANDA 207065

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.02MG;0.1MG

0

LEVONORGESTREL AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207065
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.02MG;0.1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-17
        )

)