ANDA 213317

CHEMO RESEARCH SL

FDA Drug Application

Application #213317

Documents

• Letter: 2021-01-07

Application Sponsors

ANDA 213317

CHEMO RESEARCH SL

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.02MG;1MG

0

GEMMILY

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-11-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

CHEMO RESEARCH SL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213317
            [companyName] => CHEMO RESEARCH SL
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMMILY","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.02MG;1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-09
        )

)