ANDA 209170

ACCORD HLTHCARE

FDA Drug Application

Application #209170

Application Sponsors

ANDA 209170

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.15MG,N/A;0.02MG,0.01MG

0

DESOGESTREL AND ETHINYL ESTRADIOL

DESOGESTREL; ETHINYL ESTRADIOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-06-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

NAARI PTE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209170
            [companyName] => NAARI PTE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESOGESTREL AND ETHINYL ESTRADIOL","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG,N\/A;0.02MG,0.01MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/05\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-06-05
        )

)