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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215430
Company: AXSOME

Medication Guide

Products on NDA 215430

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AUVELITY	BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE	105MG;45MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes
AUVELITY	BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE	105MG;30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215430

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	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215430Orig1s000Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215430Orig1s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/215430Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2026	SUPPL-18	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215430s009s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215430Orig1s009, s018correctedltr.pdf
11/05/2025	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215430s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215430Orig1s016ltr.pdf
04/30/2026	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215430s009s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215430Orig1s009, s018correctedltr.pdf
05/07/2024	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215430s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215430Orig1s008ltr.pdf

Labels for NDA 215430

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2026	SUPPL-18	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215430s009s018lbl.pdf
04/30/2026	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215430s009s018lbl.pdf
04/30/2026	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215430s009s018lbl.pdf
11/05/2025	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215430s016lbl.pdf
05/07/2024	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215430s008lbl.pdf
08/18/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215430Orig1s000Correctedlbl.pdf

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