ANDA 207033

ACCORD HLTHCARE

FDA Drug Application

Application #207033

Application Sponsors

ANDA 207033

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.03MG;0.15MG

0

LEVONORGESTREL AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207033
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG;0.15MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-09
        )

)