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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211230
Company: AXSOME MALTA

Medication Guide

Products on NDA 211230

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUNOSI	SOLRIAMFETOL HYDROCHLORIDE	EQ 75MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
SUNOSI	SOLRIAMFETOL HYDROCHLORIDE	EQ 150MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211230

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
03/20/2019	ORIG-2	Approval	Efficacy	STANDARD	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice on DEA Scheduling; Date of Approval – June 17, 2019
03/20/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice on DEA Scheduling; Date of Approval – June 17, 2019

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
06/28/2023	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)
12/01/2022	SUPPL-7	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)
10/20/2021	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)
10/07/2019	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)

Labels for NDA 211230

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
06/28/2023	SUPPL-9	Labeling-Medication Guide	Label (PDF)
06/28/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)
12/01/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)
12/01/2022	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)
10/20/2021	SUPPL-4	Labeling-Package Insert	Label (PDF)
10/07/2019	SUPPL-1	Labeling-Package Insert	Label (PDF)
03/20/2019	ORIG-2	Approval	Label (PDF)
03/20/2019	ORIG-1	Approval	Label (PDF)

Therapeutic Equivalents for NDA 211230

SUNOSI

TABLET;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SOLRIAMFETOL HYDROCHLORIDE	SOLRIAMFETOL HYDROCHLORIDE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	218016	HIKMA
SUNOSI	SOLRIAMFETOL HYDROCHLORIDE	EQ 75MG BASE	TABLET;ORAL	Prescription	Yes	AB	211230	AXSOME MALTA

TABLET;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SOLRIAMFETOL HYDROCHLORIDE	SOLRIAMFETOL HYDROCHLORIDE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	218016	HIKMA
SUNOSI	SOLRIAMFETOL HYDROCHLORIDE	EQ 150MG BASE	TABLET;ORAL	Prescription	Yes	AB	211230	AXSOME MALTA

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