NDA 214044

ATHENA BIOSCIENCE LLC

FDA Drug Application

Application #214044

Documents

• Letter: 2020-09-02
• Label: 2021-03-26
• Medication Guide: 2021-03-26
• Letter: 2020-09-02
• Review: 2021-07-14
• Label: 2021-09-13
• Letter: 2021-09-14

Application Sponsors

NDA 214044

ATHENA BIOSCIENCE LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

5MG/ML

0

QDOLO

TRAMADOL HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2020-09-01

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

ATHENA BIOSCIENCE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214044
            [companyName] => ATHENA BIOSCIENCE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"QDOLO","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"5MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/01\/2020","submission":"SUPPL-1","supplementCategories":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214044Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-01
        )

)