Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218016
Company: HIKMA

Products on ANDA 218016

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218016

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/19/2024	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218016

SOLRIAMFETOL HYDROCHLORIDE

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