NDA 213388

ABBVIE INC

FDA Drug Application

Application #213388

Documents

• Label: 2020-06-02
• Medication Guide: 2020-06-02
• Letter: 2020-06-02
• Review: 2020-11-04
• Label: 2021-08-03
• Medication Guide: 2021-08-03
• Letter: 2021-08-17

Application Sponsors

NDA 213388

ABBVIE INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

300MG;1MG,0.5MG;300MG

2

ORIAHNN

ELAGOLIX;ESTRADIOL NORETHINDRONE ACETATE;ELAGOLIX

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

AP

2020-05-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ABBVIE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213388
            [companyName] => ABBVIE INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/213388s000lbl.pdf#page=29"]
            [products] => [{"drugName":"ORIAHNN (COPACKAGED)","activeIngredients":"ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM","strength":"EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/29\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213388s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213388s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213388Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-29
        )

)