← FDA DRUG APPROVALS

FDA NDA · NDA215430

AUVELITY

dextromethorphan hydrobromide, bupropion hydrochloride

Sponsor: AXSOME

APPLICATION
NDA215430
TYPE
NDA
ORIGINAL APPROVAL
2022-08-18
LATEST ACTION
2026-04-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

AUVELITY · ReferencePrescription
BUPROPION HYDROCHLORIDE 105MG, DEXTROMETHORPHAN HYDROBROMIDE 30MG · TABLET, EXTENDED RELEASE · ORAL
AUVELITY · ReferencePrescription
BUPROPION HYDROCHLORIDE 105MG, DEXTROMETHORPHAN HYDROBROMIDE 45MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-04-30Labeling · Supplement 9 · standard — Label ↗AP
2026-04-30Efficacy · Supplement 18 · priority — Label ↗AP
2025-11-05Labeling · Supplement 16 · standard — Letter ↗AP
2024-05-07Labeling · Supplement 8 · standard — Letter ↗AP
2022-08-18Type 3 - New Dosage Form and Type 4 - New Combination · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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