NDA 215430

AXSOME THERAPEUTICS, INC.

FDA Drug Application

Application #215430

Documents

• Letter: 2022-08-19
• Label: 2022-08-19
• Medication Guide: 2022-08-19

Application Sponsors

NDA 215430

AXSOME THERAPEUTICS, INC.

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

45MG/105MG

0

AUVELITY

DEXTROMETHORPHAN HYDROBROMIDE AND BUPROPION HYDROCHLORIDE

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination

ORIG

1

AP

2022-08-18

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

AXSOME THERAPEUTICS, INC.

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(
    [0] => Array
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            [ApplNo] => 215430
            [companyName] => AXSOME THERAPEUTICS, INC.
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/215430Orig1s000Correctedlbl.pdf#page=25"]
            [products] => [{"drugName":"AUVELITY","activeIngredients":"DEXTROMETHORPHAN HYDROBROMIDE AND BUPROPION HYDROCHLORIDE","strength":"45MG\/105MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/18\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215430Orig1s000Correctedlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form and Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215430Orig1s000Correctedlbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215430Orig1s000Correctedltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-08-18
        )

)