FDA Approval for AUVELITY issued to AXSOME THERAPEUTICS, INC.
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 215430
Company: AXSOME THERAPEUTICS, INC.
Company: AXSOME THERAPEUTICS, INC.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AUVELITY | DEXTROMETHORPHAN HYDROBROMIDE AND BUPROPION HYDROCHLORIDE | 45MG/105MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/18/2022 | ORIG-1 | Approval | Type 3 - New Dosage Form and Type 4 - New Combination | PRIORITY |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215430Orig1s000Correctedltr.pdf |