ANDA 212706

SLAYBACK PHARMA LLC

FDA Drug Application

Application #212706

Application Sponsors

ANDA 212706

SLAYBACK PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.02MG;1MG

0

MERZEE

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-12-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

SLAYBACK PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212706
            [companyName] => SLAYBACK PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MERZEE","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.02MG;1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-18
        )

)